Trial Outcomes & Findings for Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651) (NCT NCT03374254)

NCT ID: NCT03374254

Last Updated: 2024-11-21

Results Overview

The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, \& E), if possibly, probably or definitely related to study treatment, was considered a DLT: Grade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting \>7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initiating study therapy due to a treatment-related AE that started during the DLT period, Any treatment-related toxicity that causes the participant to discontinue treatment during the DLT period, Missing \>25% of binimetinib doses as a result of drug-related AE(s), Gr 5 toxicity, Cardiac disorders and vascular disorders, Eye disorders (Retinopathy or retinal detachment Gr ≥ 3).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 116 participants
• Primary outcome timeframe: Up to approximately first 28 days of treatment
• Results posted on: 2024-11-21

Participant Flow

A total of 161 participants were screened, 116 participants were allocated, and 114 received at least 1 dose of study treatment across 14 study sites in 2 countries. This study included 2 parts: Part 1 was a dose finding phase and Part 2 was a dose confirmation phase to further examine safety and explore efficacy. Cohorts A, C, and E did not proceed to Part 2.

Participant milestones

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg Participants in Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg Participants in Cohort A will receive pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort B Part 2: Pembrolizumab + mFOLFOX7 During Part 2, participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg Participants in Cohort C received pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI Participants in Cohort D received a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort D Part 2: Pembrolizumab + FOLFIRI During Part 2, participants in Cohort D received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI Q2W plus binimetinib orally at 45 mg BID until disease progression or discontinuation.
Overall Study STARTED	6	16	15	16	11	16	16	9	11
Overall Study Treated	6	14	15	16	11	16	16	9	11
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	16	15	16	11	16	16	9	11

Reasons for withdrawal

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg Participants in Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg Participants in Cohort A will receive pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort B Part 2: Pembrolizumab + mFOLFOX7 During Part 2, participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg Participants in Cohort C received pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI Participants in Cohort D received a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort D Part 2: Pembrolizumab + FOLFIRI During Part 2, participants in Cohort D received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI Q2W plus binimetinib orally at 45 mg BID until disease progression or discontinuation.
Overall Study Death	5	16	13	11	9	12	11	6	7
Overall Study Lost to Follow-up	0	0	0	0	0	0	2	0	0
Overall Study Sponsor Decision	1	0	2	3	2	3	3	3	4
Overall Study Withdrawal by Subject	0	0	0	2	0	1	0	0	0

Baseline Characteristics

Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)

Baseline characteristics by cohort

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg n=6 Participants Participants in Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg n=16 Participants Participants in Cohort A will receive pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 n=15 Participants Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort B Part 2: Pembrolizumab + mFOLFOX7 n=16 Participants During Part 2, participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg n=11 Participants Participants in Cohort C received pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI n=16 Participants Participants in Cohort D received a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort D Part 2: Pembrolizumab + FOLFIRI n=16 Participants During Part 2, participants in Cohort D received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg n=9 Participants Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID n=11 Participants During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.	Total n=116 Participants Total of all reporting groups
Age, Continuous	55.0 Years STANDARD_DEVIATION 9.3 • n=5 Participants	59.4 Years STANDARD_DEVIATION 11.3 • n=7 Participants	55.5 Years STANDARD_DEVIATION 11.6 • n=5 Participants	50.3 Years STANDARD_DEVIATION 12.0 • n=4 Participants	54.8 Years STANDARD_DEVIATION 14.1 • n=21 Participants	56.3 Years STANDARD_DEVIATION 11.7 • n=8 Participants	52.5 Years STANDARD_DEVIATION 13.8 • n=8 Participants	57.9 Years STANDARD_DEVIATION 11.4 • n=24 Participants	48.2 Years STANDARD_DEVIATION 10.4 • n=42 Participants	54.4 Years STANDARD_DEVIATION 12.1 • n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	11 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	4 Participants n=42 Participants	50 Participants n=42 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=8 Participants	11 Participants n=8 Participants	4 Participants n=24 Participants	7 Participants n=42 Participants	66 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	8 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	15 Participants n=4 Participants	9 Participants n=21 Participants	13 Participants n=8 Participants	16 Participants n=8 Participants	8 Participants n=24 Participants	10 Participants n=42 Participants	105 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	9 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 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	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	9 Participants n=21 Participants	14 Participants n=8 Participants	13 Participants n=8 Participants	8 Participants n=24 Participants	10 Participants n=42 Participants	99 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to approximately first 28 days of treatment

Population: Population based on all participants who received treatment and that were DLT Evaluable in Part 1 of study. These populations included all allocated participants in Part 1 who received at least 1 dose of study intervention according to the study intervention they received.

The occurrence of any of the following toxicities during Part 1 of the study (the first 21 days for Cohort A, first 28 days for Cohorts B,C, D, & E), if possibly, probably or definitely related to study treatment, was considered a DLT:

Grade (Gr) 4 non hematologic toxicity, Gr 4 hematologic toxicity lasting >7 days, Gr 3 thrombocytopenia, Any non-hematologic AE ≥Gr 3 in severity, Any Gr 3 or Gr 4 non-hematologic laboratory value, Febrile neutropenia Gr 3 or Gr 4, Any prolonged delay in initiating study therapy due to a treatment-related AE that started during the DLT period, Any treatment-related toxicity that causes the participant to discontinue treatment during the DLT period, Missing >25% of binimetinib doses as a result of drug-related AE(s), Gr 5 toxicity, Cardiac disorders and vascular disorders, Eye disorders (Retinopathy or retinal detachment Gr ≥ 3).

Outcome measures

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg n=6 Participants Participants in Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg n=14 Participants Participants in Cohort A received pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 n=15 Participants Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg n=11 Participants Participants in Cohort C received pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI n=14 Participants Participants in Cohort D received a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg n=9 Participants Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID n=11 Participants During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.
Percentage of Participants Who Experienced Dose-Limiting Toxicity (DLT)	16.7 Percetange of Participants Interval 4.0 to 39.1	0.0 Percetange of Participants Interval 0.0 to 10.2	0.0 Percetange of Participants Interval 0.0 to 9.6	27.3 Percetange of Participants Interval 13.4 to 45.0	7.1 Percetange of Participants Interval 1.4 to 19.4	33.3 Percetange of Participants Interval 17.0 to 53.1	45.5 Percetange of Participants Interval 28.4 to 63.3

SECONDARY outcome

Timeframe: Up to Approximately 64 months

Population: The analysis population consisted of all evaluable participants for each cohort with a baseline scan with measurable disease by investigator assessment who received at least 1 dose of study treatment. Per protocol, the populations were analyzed by cohort and treatment combination (irrespective of dose); therefore, data by individual dose were not analyzed.

ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). The percentage of participants who experienced CR or PR is presented. Per Protocol, analysis was per cohort.

Outcome measures

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg n=20 Participants Participants in Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg n=31 Participants Participants in Cohort A received pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 n=11 Participants Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg n=32 Participants Participants in Cohort C received pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI n=20 Participants Participants in Cohort D received a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg Participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: MK-3475 200 mg Q3W + FOLFIRI Q2W + Binimetinib 45 mg BID During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	0.0 Percentage of participants Interval 0.0 to 16.8	61.3 Percentage of participants Interval 42.2 to 78.2	27.3 Percentage of participants Interval 6.0 to 61.0	25.0 Percentage of participants Interval 11.5 to 43.4	20.0 Percentage of participants Interval 5.7 to 43.7	—	—

Adverse Events

Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg

Serious events: 7 serious events

Other events: 14 other events

Deaths: 16 deaths

Cohort B Part 1: Pembrolizumab + mFOLFOX7

Serious events: 5 serious events

Other events: 15 other events

Deaths: 13 deaths

Cohort B Part 2: Pembrolizumab + mFOLFOX

Serious events: 8 serious events

Other events: 16 other events

Deaths: 12 deaths

Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg

Serious events: 7 serious events

Other events: 11 other events

Deaths: 9 deaths

Cohort D Part 1: Pembrolizumab + FOLFIRI

Serious events: 6 serious events

Other events: 16 other events

Deaths: 13 deaths

Cohort D Part 2: Pembrolizumab + FOLFIRI

Serious events: 2 serious events

Other events: 16 other events

Deaths: 11 deaths

Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 6 deaths

Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg

Serious events: 7 serious events

Other events: 11 other events

Deaths: 7 deaths

Serious adverse events

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg n=6 participants at risk Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg n=14 participants at risk Participants in Cohort A received pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 n=15 participants at risk Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort B Part 2: Pembrolizumab + mFOLFOX n=16 participants at risk During Part 2, participants in Cohort B will receive pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg n=11 participants at risk Participants in Cohort C will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI n=16 participants at risk Participants in Cohort D will receive a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort D Part 2: Pembrolizumab + FOLFIRI n=16 participants at risk During Part 2, participants in Cohort D will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) until disease progression or discontinuation	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg n=9 participants at risk Participants in Cohort E will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg n=11 participants at risk During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation. Cohort A During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Atrioventricular block second degree	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Pericardial effusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Stress cardiomyopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Visual impairment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Ascites	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Colitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Enterocolitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Intestinal obstruction	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Large intestine perforation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Mucosal inflammation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Pyrexia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Biliary dilatation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Hepatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Immune system disorders Drug hypersensitivity	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Anal abscess	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Bronchitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations COVID-19	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Diverticulitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Gastroenteritis norovirus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Hepatitis viral	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pelvic abscess	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pelvic infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pneumonia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Sepsis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Septic shock	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Urosepsis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood creatinine increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Syncope	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Confusional state	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Embolism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.

Other adverse events

Measure	Cohort A Part 1: Pembrolizumab +Binimetinib 30 mg n=6 participants at risk Cohort A received pembrolizumab (200 mg) intravenous (IV) every 3 weeks (Q3W) plus binimetinib orally at of 30 mg twice a day (BID) until disease progression or discontinuation.	Cohort A Part 1: Pembrolizumab +Binimetinib 45 mg n=14 participants at risk Participants in Cohort A received pembrolizumab (200 mg) IV Q3W plus binimetinib orally at 45 mg BID (Dose Level 2 \[DL2\]) until disease progression or discontinuation.	Cohort B Part 1: Pembrolizumab + mFOLFOX7 n=15 participants at risk Participants in Cohort B received pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort B Part 2: Pembrolizumab + mFOLFOX n=16 participants at risk During Part 2, participants in Cohort B will receive pembrolizumab (200 mg) IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort C Part 1: Pembrolizumab + mFOLFOX7 + Binimetinib 30 mg n=11 participants at risk Participants in Cohort C will receive pembrolizumab 200 mg IV Q3W plus mFOLFOX7 (oxaliplatin 85mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; fluorouracil \[5-FU\] 2400 mg/m\^2 over 46-48 hours) IV Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort D Part 1: Pembrolizumab + FOLFIRI n=16 participants at risk Participants in Cohort D will receive a standard dose (DL1) of pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) IV Q2W until disease progression or discontinuation.	Cohort D Part 2: Pembrolizumab + FOLFIRI n=16 participants at risk During Part 2, participants in Cohort D will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) until disease progression or discontinuation	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 30 mg n=9 participants at risk Participants in Cohort E will receive pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W in combination with binimetinib orally at a starting dose of 30 mg BID until disease progression or discontinuation.	Cohort E Part 1: Pembrolizumab + FOLFIRI + Binimetinib 45 mg n=11 participants at risk During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation. Cohort A During Part 2, participants in Cohort E received pembrolizumab 200 mg IV Q3W plus FOLFIRI (irinotecan 180 mg/m\^2; leucovorin \[calcium folinate\] 400 mg/m\^2; 5-FU 2400 mg/m\^2 over 46-48 hours) Q2W plus binimetinib orally at the starting dose of 45 mg BID until disease progression or discontinuation.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	56.2% 9/16 • Number of events 21 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	55.6% 5/9 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 5/15 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 12 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 21 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	44.4% 4/9 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 5/15 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Angina pectoris	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Arrhythmia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Atrioventricular block second degree	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Bradycardia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Bundle branch block right	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Palpitations	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Pericardial effusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Tachycardia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Cardiac disorders Ventricular arrhythmia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Ear and labyrinth disorders Ear congestion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Ear and labyrinth disorders Ear pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Endocrine disorders Goitre	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Endocrine disorders Hypoparathyroidism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Endocrine disorders Secondary adrenocortical insufficiency	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Astigmatism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Blindness transient	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Cataract	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Chloropsia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Conjunctival haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Conjunctival hyperaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Conjunctival oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Diabetic retinopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Dry eye	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eye discharge	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eye irritation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eye pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eye swelling	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eyelid ptosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Eyelid rash	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Lacrimation increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Maculopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Ocular discomfort	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Ocular hypertension	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Papilloedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Periorbital oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Photophobia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Photopsia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Presbyopia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Retinal detachment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Retinal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Retinopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Saccadic eye movement	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Serous retinal detachment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Subretinal fluid	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Vision blurred	33.3% 2/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Visual field defect	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Visual impairment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Vitreous detachment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Eye disorders Vitreous floaters	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal mass	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal pain	33.3% 2/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	54.5% 6/11 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	62.5% 10/16 • Number of events 12 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 3/9 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Abnormal faeces	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal erythema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal fissure	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal fistula	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal pruritus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anal rash	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Anorectal discomfort	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Ascites	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Cheilitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Colitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	46.7% 7/15 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	62.5% 10/16 • Number of events 15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	63.6% 7/11 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	44.4% 4/9 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	54.5% 6/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Dental caries	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Diarrhoea	83.3% 5/6 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	57.1% 8/14 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	73.3% 11/15 • Number of events 17 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	50.0% 8/16 • Number of events 19 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	90.9% 10/11 • Number of events 27 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	81.2% 13/16 • Number of events 30 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	75.0% 12/16 • Number of events 25 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	88.9% 8/9 • Number of events 21 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	81.8% 9/11 • Number of events 22 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Dyschezia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Enteritis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Eructation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Faeces discoloured	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Food poisoning	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gastric ulcer	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gingival bleeding	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gingival pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Gingival swelling	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Glossodynia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Haematochezia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Leukoplakia oral	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Lip oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Lip swelling	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Melaena	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Mucous stools	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	50.0% 7/14 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	73.3% 11/15 • Number of events 18 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	75.0% 12/16 • Number of events 43 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	81.8% 9/11 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	56.2% 9/16 • Number of events 20 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 20 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	88.9% 8/9 • Number of events 14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	100.0% 11/11 • Number of events 18 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Oral pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Peptic ulcer	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Proctalgia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Rectal discharge	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Rectal tenesmus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Saliva discolouration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Steatorrhoea	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	46.7% 7/15 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 3/9 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	45.5% 5/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Tongue disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Tongue erythema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Tongue ulceration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Tooth discolouration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Toothache	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	50.0% 7/14 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	62.5% 10/16 • Number of events 29 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	63.6% 7/11 • Number of events 15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 22 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	56.2% 9/16 • Number of events 20 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	77.8% 7/9 • Number of events 12 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	72.7% 8/11 • Number of events 16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Asthenia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Catheter site pruritus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Catheter site rash	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Chest discomfort	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Chest pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Chills	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Cyst rupture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Drug withdrawal syndrome	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Face oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Fatigue	66.7% 4/6 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	71.4% 10/14 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	73.3% 11/15 • Number of events 15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	68.8% 11/16 • Number of events 19 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	63.6% 7/11 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	56.2% 9/16 • Number of events 15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	50.0% 8/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	77.8% 7/9 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	63.6% 7/11 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Feeling cold	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Feeling hot	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Feeling jittery	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Gait disturbance	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Generalised oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Influenza like illness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Infusion site pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Infusion site pruritus	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Localised oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Malaise	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Mucosal inflammation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Non-cardiac chest pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Oedema peripheral	16.7% 1/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	42.9% 6/14 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	55.6% 5/9 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Peripheral swelling	16.7% 1/6 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Pyrexia	33.3% 2/6 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	54.5% 6/11 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	44.4% 4/9 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Swelling face	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Temperature intolerance	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Vaccination site reaction	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
General disorders Vascular device occlusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Hepatic pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Hyperbilirubinaemia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Hepatobiliary disorders Jaundice	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Immune system disorders Contrast media reaction	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Immune system disorders Drug hypersensitivity	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Immune system disorders Hypersensitivity	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Immune system disorders Seasonal allergy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Acarodermatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Anal abscess	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Bacteraemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Bacterial infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Bronchitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations COVID-19	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Candida infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Cellulitis	16.7% 1/6 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Clostridium difficile infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Conjunctivitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Cystitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Ear infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Escherichia urinary tract infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Eye infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Folliculitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Fungal foot infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Fungal infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Fungal skin infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Furuncle	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Gastroenteritis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Gastroenteritis viral	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Gingivitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Herpes simplex reactivation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Herpes zoster	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Hordeolum	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Myelitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Nail infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Oral candidiasis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Oral herpes	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Otitis media	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Paronychia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pelvic infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Periodontitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pharyngitis streptococcal	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Pneumonia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Rash pustular	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Rhinovirus infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Sinusitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Skin infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Stoma site infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Streptococcal bacteraemia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Tonsillitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Vaginal infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Vascular device infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Viral infection	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Anastomotic haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Anastomotic ulcer	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site erythema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site haemorrhage	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site irritation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Stoma site pruritus	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Sunburn	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Amylase increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	45.5% 5/11 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood albumin decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	45.5% 5/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood calcium decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood cholesterol increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood creatine phosphokinase increased	33.3% 2/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood creatinine increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood glucose increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood lactate dehydrogenase increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood lactic acid increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood magnesium decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood phosphorus decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Carcinoembryonic antigen increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Ejection fraction decreased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Electrocardiogram QT prolonged	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Glomerular filtration rate decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Haemoglobin decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations International normalised ratio increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Intraocular pressure increased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Lipase decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Lipase increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Lymphocyte count decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Monocyte count decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Neutrophil count decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Platelet count decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Procalcitonin increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Protein urine present	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Prothrombin time prolonged	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Red blood cell sedimentation rate increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Respiratory rate increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Serum ferritin increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Urine output decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Weight decreased	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations Weight increased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Investigations White blood cell count decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 13 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	44.4% 4/9 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Gout	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 2/6 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	21.4% 3/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 2/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	21.4% 3/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	55.6% 5/9 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Groin pain	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Joint noise	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Joint stiffness	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Mastication disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer fatigue	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Erythroplasia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Ageusia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Altered state of consciousness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Amnesia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Burning sensation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Cholinergic syndrome	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Disturbance in attention	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Dizziness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 3/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Dysaesthesia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Dysarthria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Dysgeusia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Encephalopathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Head discomfort	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Headache	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	55.6% 5/9 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Hypoaesthesia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Lethargy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Lhermitte's sign	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Memory impairment	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Migraine	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Neuralgia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	46.7% 7/15 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	75.0% 12/16 • Number of events 19 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	72.7% 8/11 • Number of events 12 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Paraesthesia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Parosmia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	53.3% 8/15 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	36.4% 4/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Polyneuropathy	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Presyncope	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Sciatica	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Sinus headache	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Somnolence	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Syncope	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Taste disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Nervous system disorders Tremor	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Affect lability	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Agitation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Anxiety	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Confusional state	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Depression	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Emotional distress	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Psychiatric disorders Mental status changes	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Chromaturia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Dysuria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Glycosuria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Haematuria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Breast tenderness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Dyspareunia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Genital burning sensation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Genital rash	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Nipple pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Pelvic discomfort	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Pelvic pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Penile pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Scrotal oedema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Testicular pain	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Vaginal stricture	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Vulvovaginal erythema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Reproductive system and breast disorders Vulvovaginal pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	21.4% 3/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 7 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Dysaesthesia pharynx	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	28.6% 4/14 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 3/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Acne	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Acne cystic	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	37.5% 6/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Blister	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Dermatitis acneiform	66.7% 4/6 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	35.7% 5/14 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	72.7% 8/11 • Number of events 9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	66.7% 6/9 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	45.5% 5/11 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	33.3% 3/9 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Erythema	16.7% 1/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Hair texture abnormal	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Nail disorder	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Papule	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	14.3% 2/14 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	26.7% 4/15 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	43.8% 7/16 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	66.7% 6/9 • Number of events 8 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Rash	50.0% 3/6 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	35.7% 5/14 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	45.5% 5/11 • Number of events 17 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Rash maculo-papular	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	20.0% 3/15 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	25.0% 4/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin plaque	16.7% 1/6 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Skin wrinkling	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 4 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Collateral circulation	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Embolism	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	12.5% 2/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Flushing	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Hot flush	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	7.1% 1/14 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	31.2% 5/16 • Number of events 10 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 5 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.8% 3/16 • Number of events 6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	22.2% 2/9 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Hypotension	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	13.3% 2/15 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	18.2% 2/11 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 2 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	11.1% 1/9 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	27.3% 3/11 • Number of events 3 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Pallor	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.2% 1/16 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Thrombosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	6.7% 1/15 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.
Vascular disorders Vena cava thrombosis	0.00% 0/6 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/14 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/15 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	9.1% 1/11 • Number of events 1 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/16 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/9 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.	0.00% 0/11 • Up to approximately 64 months Serious and Other adverse events (AEs) includes all participants who received ≥1 dose of study drug. All-Cause Mortality includes all allocated participants for non-randomized studies. Per protocol, disease progression of cancer in study was not considered an AE unless deemed related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded AEs. Data is treatment-based reporting.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: clinicaltrialsdisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
• Publication restrictions are in place

Restriction type: OTHER