Trial Outcomes & Findings for COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC (NCT NCT04068610)

NCT ID: NCT04068610

Last Updated: 2025-12-11

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)
• Results posted on: 2025-12-11

Participant Flow

A total of 61 participants were randomized in this study of which 59 participants received treatment.

Participant milestones

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (C1): FOLFOX + Bevacizumab Participants in Part 2 control 1 arm (C1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Overall Study STARTED	7	26	26
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	7	26	26

Reasons for withdrawal

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (C1): FOLFOX + Bevacizumab Participants in Part 2 control 1 arm (C1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Overall Study Death	4	8	13
Overall Study Lost to Follow-up	0	2	0
Overall Study Withdrawal by Subject	0	4	2
Overall Study Other	3	12	11

Baseline Characteristics

COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC

Baseline characteristics by cohort

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (C1): FOLFOX + Bevacizumab n=26 Participants Participants in Part 2 control 1 arm (C1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Total n=59 Participants Total of all reporting groups
Age, Continuous	59.4 Years STANDARD_DEVIATION 12.4 • n=237 Participants	55.5 Years STANDARD_DEVIATION 13.5 • n=243 Participants	59.8 Years STANDARD_DEVIATION 12.5 • n=480 Participants	57.9 Years STANDARD_DEVIATION 12.9 • n=639 Participants
Sex: Female, Male Female	3 Participants n=237 Participants	7 Participants n=243 Participants	11 Participants n=480 Participants	21 Participants n=639 Participants
Sex: Female, Male Male	4 Participants n=237 Participants	19 Participants n=243 Participants	15 Participants n=480 Participants	38 Participants n=639 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=237 Participants	4 Participants n=243 Participants	1 Participants n=480 Participants	5 Participants n=639 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=237 Participants	19 Participants n=243 Participants	23 Participants n=480 Participants	49 Participants n=639 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants	3 Participants n=243 Participants	2 Participants n=480 Participants	5 Participants n=639 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants	0 Participants n=639 Participants
Race (NIH/OMB) Asian	0 Participants n=237 Participants	1 Participants n=243 Participants	2 Participants n=480 Participants	3 Participants n=639 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants	0 Participants n=639 Participants
Race (NIH/OMB) Black or African American	0 Participants n=237 Participants	1 Participants n=243 Participants	0 Participants n=480 Participants	1 Participants n=639 Participants
Race (NIH/OMB) White	7 Participants n=237 Participants	20 Participants n=243 Participants	23 Participants n=480 Participants	50 Participants n=639 Participants
Race (NIH/OMB) More than one race	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants	0 Participants n=639 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=237 Participants	4 Participants n=243 Participants	1 Participants n=480 Participants	5 Participants n=639 Participants

PRIMARY outcome

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1 Any TEAE	7 Participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part 1 Any TESAE	1 Participants	—

PRIMARY outcome

Timeframe: From Day 1 to 28 days after the first dose of novel oncology therapy (durvalumab and oleclumab)

Population: The DLT evaluable population included all participants in Part 1 safety run-in who received the full prescribed dose of durvalumab and ≥ 75% of the prescribed number of doses of FOLFOX plus bevacizumab and the other novel oncology therapy and completed the safety follow-up through the DLT evaluation period or experienced any DLT.

DLT: Any study drug related Grade (G)3 or higher toxicity including: any G3/G4 immune-mediated AE, any G3/4 noninfectious pneumonitis/colitis, transaminase elevation (TE) >8x upper limit of normal (ULN) or total bilirubin (TBL) >5xULN, increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=3xULN along with TBL >=2xULN, isolated liver TE >5 but =<8xULN or isolated TBL >3 but =<5xULN that does not downgrade to G1 or less within 14 days of onset, G3 nausea/vomiting/diarrhea that does not resolve to G2 or less within 3 days of maximal supportive care (MSC), G3/4 febrile neutropenia, G3/4 neutropenia not associated with fever/systemic infection, G4 anemia, G3 anemia with clinical sequelae/requires >2 units of red blood cells transfusion, thrombocytopenia (G4 >=7 days, G3 that did not improve by at least 1 grade within 7 days, G3/4 associated with G3/higher hemorrhage).

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Dose Limiting Toxicities (DLTs) in Part 1	0 Participants	—

PRIMARY outcome

Timeframe: Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

Number of participants with at least common terminology criteria for adverse events (CTCAE v5.0) 2-grade shift from baseline (last assessment prior to first dose) to worst toxicity grade in clinical laboratory parameters are reported. Clinical laboratory parameter analysis included hematology, clinical chemistry, coagulation, and urinalysis.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Hemoglobin (Hypo)	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Lymphocytes (Hypo)	2 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Neutrophils	4 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Leukocytes (Hypo)	3 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Activated Partial Thromboplastin Time	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Albumin	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Amylase	2 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Bilirubin	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Calcium Corrected (Hypo)	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Creatine Kinase	2 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Creatinine	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Gamma Glutamyl Transferase	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Glucose	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Lipase	5 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Magnesium (Hyper)	1 Participants	—
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 1 Magnesium (Hypo)	1 Participants	—

PRIMARY outcome

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, and pulse rate).

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1 Pyrexia	2 Participants	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1 Temperature intolerance	1 Participants	—
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 1 Hypertension	3 Participants	—

PRIMARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: Intent-to-treat (ITT) population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

The OR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 criteria. The CR is defined as disappearance of all target lesions (TLs) and non-target lesions (NTLs), normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesion. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in Part 2	46.2 Percentage of Participants Interval 26.6 to 66.6	61.5 Percentage of Participants Interval 40.6 to 79.8

SECONDARY outcome

Timeframe: First dose (Day 1) through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

The OR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1 criteria. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With OR Per RECIST v1.1 in Part 1	71.4 Percentage of Participants Interval 29.0 to 96.3	—

SECONDARY outcome

Timeframe: First dose (Day 1) through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

BOR: best response including CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) among all overall responses based on application of RECIST v1.1 to investigator assessments. CR: disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis <10 mm, and no new lesions. PR: at least 30% decrease in the SoD of TL (compared to baseline) and no new NTL. Confirmation of CR and PR is required after 4 weeks. PD: at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5mm, or unequivocal progression of existing NTL, or new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in at least 8 weeks from first dose of study drug. NE: either when no or only a subset of lesion measurements are made at an assessment. Number of participants with BOR are reported.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Best Overall Response (BOR) Per RECIST v1.1 in Part 1 CR	0 Participants	—
Best Overall Response (BOR) Per RECIST v1.1 in Part 1 PR	5 Participants	—
Best Overall Response (BOR) Per RECIST v1.1 in Part 1 SD >=8 weeks	2 Participants	—
Best Overall Response (BOR) Per RECIST v1.1 in Part 1 PD	0 Participants	—
Best Overall Response (BOR) Per RECIST v1.1 in Part 1 NE	0 Participants	—

SECONDARY outcome

Timeframe: First dose (Day 1) through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. The DoR was assessed for only those participants who had OR.

The DoR is defined as the time from the first documentation of a confirmed response (CR or PR) until the first documentation of PD or death due to any cause, whichever occurs first. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The DoR was analyzed using Kaplan-Meier method.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=5 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Duration of Response (DoR) Per RECIST v1.1 in Part 1	6.0 Months Interval 5.5 to Upper limit of 95% CI was not reached because an insufficient number of participants had DoR.	—

SECONDARY outcome

Timeframe: First dose (Day 1) through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

The DC is defined as BOR of confirmed CR, confirmed PR, or stable disease (SD; maintained for ≥ 16 weeks) per RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants with SD will be included in the DC if they maintain SD for >= 16 weeks from start of treatment.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With Disease Control (DC) Per RECIST v1.1 in Part 1	100 Percentage of Participants Interval 59.0 to 100.0	—

SECONDARY outcome

Timeframe: Assignment through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

The PFS is defined as the time from assignment until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. Assignment occurred between Day -3 and -1.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Progression-Free Survival (PFS) Per RECIST v1.1 in Part 1	9.5 Months Interval 7.8 to 18.2	—

SECONDARY outcome

Timeframe: Assignment through 12 months

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

The PFS is defined as the time from assignment until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. The percentage of participants progression free and alive at 12 months (PFS-12) are reported. Assignment occurred between Day -3 and -1.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With PFS at 12 Months (PFS-12) Per RECIST v1.1 in Part 1	28.6 Percentage of Participants Interval 4.1 to 61.2	—

SECONDARY outcome

Timeframe: First dose (Day 1) through end of study (approximately 2.8 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

The OS is defined as the time from first dose until death due to any cause. The overall survival was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Overall Survival (OS) Per RECIST v1.1 in Part 1	30.1 Months Interval 11.9 to Upper limit of 95% CI could not be derived due to insufficient events being observed.	—

SECONDARY outcome

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With TEAEs and TESAEs in Part 2 Any TEAE	26 Participants	26 Participants
Number of Participants With TEAEs and TESAEs in Part 2 Any TESAE	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) through 90 days after the last dose of study drug (approximately 2.6 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received. Here, number analyzed (n) denotes number of participants analyzed for the specified parameter.

Number of participants with at least CTCAE v5.0 2-grade shift from baseline (last assessment prior to first dose) to worst toxicity grade in clinical laboratory parameters are reported. Clinical laboratory parameter analysis included hematology, clinical chemistry, coagulation, and urinalysis.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Activated Partial Thromboplastin Time	5 Participants	5 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Lymphocytes (Hyper)	0 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Lymphocytes (Hypo)	3 Participants	6 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Neutrophils	7 Participants	8 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Platelets	3 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Leukocytes (Hypo)	2 Participants	4 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Albumin	0 Participants	3 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Creatinine	2 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Gamma Glutamyl Transferase	5 Participants	4 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Sodium (Hypo)	2 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Hemoglobin (Hypo)	0 Participants	1 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Alkaline Phosphatase	1 Participants	1 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Alanine Aminotransferase	2 Participants	1 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Amylase	7 Participants	3 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Aspartate Aminotransferase	1 Participants	0 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Bilirubin	1 Participants	1 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Calcium Corrected (Hypo)	0 Participants	1 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Creatine Kinase	2 Participants	3 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Potassium (Hyper)	0 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Potassium (Hypo)	0 Participants	2 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Lipase	12 Participants	15 Participants
Number of Participants With at Least 2-Grade Shift From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters in Part 2 Magnesium (Hypo)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years)

Population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, and pulse rate).

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Ventricular tachycardia	1 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Supraventricular tachycardia	1 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Pyrexia	3 Participants	5 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Temperature intolerance	5 Participants	5 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Hypertension	4 Participants	4 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part 2 Hypotension	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

BOR: best response including CR, PR, SD, PD, NE among all overall responses based on application of RECIST v1.1 to investigator assessments. CR: disappearance of all TLs, NTLs, normalization of tumor marker level, any pathological lymph nodes (target, non-target) must have reduction in short axis <10 mm, no new lesions. PR: at least 30% decrease in the SoD of TL (compared to baseline) and no new NTL. Confirmation of CR, PR is required after 4 weeks. PD: at least a 20% increase in SoDs of TLs, taking as reference smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in at least 8 weeks from first dose of study drug. NE: either when no or only a subset of lesion measurements are made at an assessment. Number of participants with BOR are reported. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
BOR Per RECIST v1.1 in Part 2 CR	0 Participants	1 Participants
BOR Per RECIST v1.1 in Part 2 PR	12 Participants	15 Participants
BOR Per RECIST v1.1 in Part 2 SD >=8 weeks	11 Participants	6 Participants
BOR Per RECIST v1.1 in Part 2 PD	1 Participants	3 Participants
BOR Per RECIST v1.1 in Part 2 NE	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to. The DoR was assessed for only those participants who had OR.

The DoR is defined as the time from the first documentation of a confirmed response (CR or PR) until the first documentation of PD or death due to any cause, whichever occurs first. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The DoR was analyzed using Kaplan-Meier method. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=12 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=16 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
DoR Per RECIST v1.1 in Part 2	7.7 Months Interval 4.6 to 15.4	10.3 Months Interval 5.8 to Upper limit of 95% CI was not reached because an insufficient number of participants had DoR.

SECONDARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

The DC is defined as BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) per RECIST v1.1. The CR is defined as disappearance of all TLs and NTLs, normalization of tumor marker level, any pathological lymph nodes (target and non-target) must have reduction in short axis < 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the SoD of TLs (compared to baseline) and no new lesion. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants with SD will be included in the DC if they maintain SD for >= 16 weeks from start of treatment. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With DC Per RECIST v1.1 in Part 2	88.5 Percentage of Participants Interval 69.8 to 97.6	84.6 Percentage of Participants Interval 65.1 to 95.6

SECONDARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

The PFS is defined as the time from randomization until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
PFS Per RECIST v1.1 in Part 2	11.1 Months Interval 7.3 to 16.2	10.9 Months Interval 6.9 to 15.1

SECONDARY outcome

Timeframe: Randomization through 12 months

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

The PFS is defined as the time from randomization until the first documentation of PD or death due to any cause, whichever occurs first, regardless of whether the participant received subsequent anticancer therapy prior to progression. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing NTL, or new lesions. The PFS was analyzed using Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. The percentage of participants progression free and alive at 12 months (PFS-12) are reported. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Percentage of Participants With PFS at 12 Months (PFS-12) Per RECIST v1.1 in Part 2	38.6 Percentage of Participants Interval 18.6 to 58.3	36.1 Percentage of Participants Interval 17.1 to 55.5

SECONDARY outcome

Timeframe: Randomization through end of study (approximately 2.6 years)

Population: The ITT population included participants who received any study drug and were analyzed according to the treatment group they were randomized to.

The OS is defined as the time from randomization until death due to any cause. The overall survival was analyzed using the Kaplan-Meier method based on application of RECIST v1.1 to investigator assessments. In Part 2, randomization occurred between Day -8 and the same date as dosing.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
OS Per RECIST v1.1 in Part 2	NA Months Interval 20.6 to Median and upper limit of 95% CI could not be derived due to insufficient events being observed.	22.4 Months Interval 10.6 to Upper limit of 95% CI could not be derived due to insufficient events being observed.

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 1 of Cycle 1, 3, 7, 13; Part 2 (E1): Pre-dose on Day 1 of Cycle 1, 3, 7, 13, and 27

Population: Pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of any study drug with at least 1 reportable PK concentration. Here, number of participants analyzed denotes those participants who were analyzed for this outcome measure. Number analyzed (n) denotes those participants who had adequate serum samples.

Serum concentrations of durvalumab collected over time in Part 1 (S1) and Part 2 (E1) are reported. The lower limit of quantification (LLOQ) for durvalumab was considered to be 50 ng/mL.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=21 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1) Cycle 1 Day 1	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.
Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1) Cycle 3 Day 1	67980 ng/mL Geometric Coefficient of Variation 20.31	48600 ng/mL Geometric Coefficient of Variation 39.67
Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1) Cycle 7 Day 1	112500 ng/mL Geometric Coefficient of Variation 28.63	97610 ng/mL Geometric Coefficient of Variation 46.56
Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1) Cycle 13 Day 1	101500 ng/mL Geometric Coefficient of Variation 30.22	147000 ng/mL Geometric Coefficient of Variation 30.57
Serum Concentrations of Durvalumab in Part 1 (S1) and Part 2 (E1) Cycle 27 Day 1	—	120700 ng/mL Geometric Coefficient of Variation 29.83

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day 1 of Cycle 1, 2, 7, and 13; Part 2 (E1): Pre-dose on Day 1 of Cycle 1, 2, 7, 13, and 27

Population: The PK evaluable population included participants who received at least 1 dose of any study drug with at least 1 reportable PK concentration. Here, number of participants analyzed denotes those participants who were analyzed for this outcome measure. Number analyzed (n) denotes those participants who had adequate serum samples.

Serum concentrations of oleclumab collected over time in Part 1 (S1) and Part 2 (E1) are reported. The LLOQ for oleclumab was considered to be 1 µg/mL.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=22 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1) Cycle 1 Day 1	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.	NA µg/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.
Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1) Cycle 2 Day 1	111.2 µg/mL Geometric Coefficient of Variation 25.38	69.81 µg/mL Geometric Coefficient of Variation 199.1
Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1) Cycle 7 Day 1	186.5 µg/mL Geometric Coefficient of Variation 53.45	159.8 µg/mL Geometric Coefficient of Variation 81.62
Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1) Cycle 13 Day 1	146.7 µg/mL Geometric Coefficient of Variation 24.43	170.1 µg/mL Geometric Coefficient of Variation 35.77
Serum Concentrations of Oleclumab in Part 1 (S1) and Part 2 (E1) Cycle 27 Day 1	—	107.9 µg/mL Geometric Coefficient of Variation 30.42

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycle 1, 2, 7, 13, and 27

Population: The PK evaluable population included participants who received at least 1 dose of any study drug with at least 1 reportable PK concentration. Here, number analyzed denotes those participants who had adequate serum samples.

Serum concentrations of bevacizumab collected over time in Part 1 (S1) are reported. The LLOQ for bevacizumab was considered to be 500 ng/mL.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Serum Concentrations of Bevacizumab in Part 1 (S1) Cycle 1 Day 1	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.	—
Serum Concentrations of Bevacizumab in Part 1 (S1) Cycle 2 Day 1	36090 ng/mL Geometric Coefficient of Variation 16.55	—
Serum Concentrations of Bevacizumab in Part 1 (S1) Cycle 7 Day 1	73350 ng/mL Geometric Coefficient of Variation 39.94	—
Serum Concentrations of Bevacizumab in Part 1 (S1) Cycle 13 Day 1	70370 ng/mL Geometric Coefficient of Variation 30.52	—
Serum Concentrations of Bevacizumab in Part 1 (S1) Cycle 27 Day 1	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and geometric CV% were not calculated as the concentration was below the LLOQ.	—

SECONDARY outcome

Timeframe: Part 1: Pre-dose on Day(D)1 of Cycles(C)1 (baseline [BL]), 3, 7, 13, and 90 days post last dose of study drug (approximately 2.8 years); Part 2(E1):Pre-dose on D1 of C1 (BL), 3, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.6 years)

Population: The ADA evaluable population included all participants who received at least 1 dose of any study drug, who have a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who had adequate ADA sample.

Number of participants with positive ADA to durvalumab in Part 1 (S1) and Part 2 (E1) are reported.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=20 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at baseline	0 Participants	2 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 3 Day 1	0 Participants	1 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 7 Day 1	0 Participants	0 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 13 Day 1	0 Participants	0 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 27 Day 1	—	0 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab in Part 1 (S1) and Part 2 (E1) ADA positive at 90 days post last dose	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part 1: Pre-dose on D1 of C1 (BL), 2, 7, 13, and 90 days post last dose of study drug (approximately 2.8 years); Part 2 (E1): Pre-dose on D1 of C1 (BL), 2, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.6 years)

Population: The ADA evaluable population included all participants who received at least 1 dose of any study drug, who have a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who had adequate ADA sample.

Number of participants with positive ADA to oleclumab in Part 1 (S1) and Part 2 (E1) are reported.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=21 Participants Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at baseline	0 Participants	0 Participants
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 2 Day 1	0 Participants	2 Participants
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 7 Day 1	0 Participants	0 Participants
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 13 Day 1	0 Participants	0 Participants
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at Cycle 27 Day 1	—	0 Participants
Number of Participants With Positive ADA to Oleclumab in Part 1 (S1) and Part 2 (E1) ADA positive at 90 days post last dose	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose on D1 of C1 (BL), 2, 7, 13, 27, and 90 days post last dose of study drug (approximately 2.8 years)

Population: The ADA evaluable population included all participants who received at least 1 dose of any study drug, who have a non-missing baseline ADA result and at least 1 non-missing post-baseline ADA result. Here, number analyzed (n) denotes those participants who had adequate ADA sample.

Number of participants with positive ADA to bevacizumab in Part 1 (S1) are reported.

Outcome measures

Measure	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 Participants Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at baseline	0 Participants	—
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at Cycle 2 Day 1	5 Participants	—
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at Cycle 7 Day 1	7 Participants	—
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at Cycle 13 Day 1	5 Participants	—
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at Cycle 27 Day 1	1 Participants	—
Number of Participants With Positive ADA to Bevacizumab in Part 1 (S1) ADA positive at 90 days post last dose	4 Participants	—

Adverse Events

Part 2 (C1): FOLFOX + Bevacizumab

Serious events: 7 serious events

Other events: 25 other events

Deaths: 8 deaths

Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab

Serious events: 1 serious events

Other events: 7 other events

Deaths: 4 deaths

Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab

Serious events: 12 serious events

Other events: 26 other events

Deaths: 13 deaths

Serious adverse events

Measure	Part 2 (C1): FOLFOX + Bevacizumab n=26 participants at risk Participants in Part 2 control 1 arm (C1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 participants at risk Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 participants at risk Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Cardiac disorders Ventricular tachycardia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Blood bilirubin increased	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Bursitis	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Lumbar radiculopathy	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Renal failure	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Ascites	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Colitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Intestinal obstruction	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Intestinal perforation	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Large intestinal obstruction	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Large intestine perforation	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Pyrexia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholangitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Covid-19	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Covid-19 pneumonia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Peritonitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Pneumonia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Rectal abscess	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Sepsis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Stoma complication	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

Other adverse events

Measure	Part 2 (C1): FOLFOX + Bevacizumab n=26 participants at risk Participants in Part 2 control 1 arm (C1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) in combination with IV bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 1 (S1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=7 participants at risk Participants in Part 1 safety run-in arm (S1) received intravenous (IV) infusions of FOLFOX (5-fluorouracil \[5-FU\]: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg every 4 weeks (Q4W) and IV oleclumab 3000 mg every 2 weeks (Q2W) till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.	Part 2 (E1): FOLFOX + Bevacizumab + Durvalumab + Oleclumab n=26 participants at risk Participants in Part 2 experimental 1 arm (E1) received IV infusions of FOLFOX (5-FU: 2400 mg/m\^2 over 46-48 hours \[Day 1 and 2 of every 14-day Cycle\], oxaliplatin: 85 mg/m\^2, folinic acid: 400 mg/m\^2) and bevacizumab 5 mg/kg on Day 1 of every Cycle (14-day cycle) in combination with IV durvalumab 1500 mg Q4W and IV oleclumab 3000 mg Q2W till 4 doses (Cycle 4) then Q4W starting on Cycle 5 Day 1 until disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met.
Investigations Amylase increased	19.2% 5/26 • Number of events 8 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Pain	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Aspartate aminotransferase increased	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Blood alkaline phosphatase increased	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Blood creatine phosphokinase increased	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Blood creatinine increased	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Gamma-glutamyltransferase increased	15.4% 4/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations International normalised ratio increased	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Lipase increased	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Neutrophil count decreased	15.4% 4/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	57.1% 4/7 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Tinnitus	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Platelet count decreased	15.4% 4/26 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Weight decreased	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Weight increased	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations White blood cell count decreased	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Decreased appetite	19.2% 5/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	30.8% 8/26 • Number of events 9 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Dehydration	11.5% 3/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Vertigo	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypokalaemia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyponatraemia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypophosphataemia	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Endocrine disorders Hypothyroidism	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Increased appetite	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Back pain	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Bone pain	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Eye disorders Vision blurred	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Neck pain	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Amnesia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Cognitive disorder	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Dizziness	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Dysaesthesia	3.8% 1/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Eye disorders Visual acuity reduced	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Dysgeusia	30.8% 8/26 • Number of events 8 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Headache	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Hypoaesthesia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Memory impairment	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Neuropathy peripheral	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	19.2% 5/26 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Neurotoxicity	7.7% 2/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Paraesthesia	26.9% 7/26 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	71.4% 5/7 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	19.2% 5/26 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Peripheral sensory neuropathy	42.3% 11/26 • Number of events 18 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	71.4% 5/7 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	38.5% 10/26 • Number of events 10 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Eye disorders Vitreous floaters	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Presyncope	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Syncope	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Taste disorder	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Nervous system disorders Tremor	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Psychiatric disorders Anxiety	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Psychiatric disorders Depression	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Psychiatric disorders Insomnia	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Psychiatric disorders Irritability	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Acute kidney injury	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Dysuria	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal hernia	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Haematuria	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Pollakiuria	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Proteinuria	15.4% 4/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary hesitation	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary incontinence	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary retention	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Aphonia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain	19.2% 5/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.1% 6/26 • Number of events 6 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Laryngospasm	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain upper	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Acne	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Alopecia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Angioedema	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Blister	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Dry skin	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Anaemia	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Ascites	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Night sweats	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Onychoclasis	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Photosensitivity reaction	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Urticaria	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Embolism	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Hot flush	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Hypertension	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	42.9% 3/7 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Hypotension	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Phlebitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Vascular disorders Venous thrombosis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Constipation	34.6% 9/26 • Number of events 11 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	42.9% 3/7 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	46.2% 12/26 • Number of events 13 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Diarrhoea	46.2% 12/26 • Number of events 16 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	71.4% 5/7 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	53.8% 14/26 • Number of events 19 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Dry mouth	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Dysphagia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Flatulence	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Haemorrhoids	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Mouth ulceration	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Nausea	50.0% 13/26 • Number of events 16 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	46.2% 12/26 • Number of events 12 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Oral pain	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Proctalgia	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Neutropenia	7.7% 2/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Rectal haemorrhage	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Rectal obstruction	3.8% 1/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Retching	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Stomatitis	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	42.9% 3/7 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	30.8% 8/26 • Number of events 9 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Vomiting	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	23.1% 6/26 • Number of events 13 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Asthenia	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Chills	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Crepitations	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Fatigue	38.5% 10/26 • Number of events 16 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	71.4% 5/7 • Number of events 7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	42.3% 11/26 • Number of events 12 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Feeling cold	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Thrombocytopenia	3.8% 1/26 • Number of events 10 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Influenza like illness	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Localised oedema	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Malaise	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Mucosal inflammation	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Oedema peripheral	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Peripheral swelling	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Pyrexia	11.5% 3/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	28.6% 2/7 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	19.2% 5/26 • Number of events 11 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
General disorders Temperature intolerance	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	19.2% 5/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Cardiac disorders Angina pectoris	3.8% 1/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatic steatosis	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Immune system disorders Seasonal allergy	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Anorectal infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Bronchitis	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Covid-19	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Candida infection	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Cellulitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Conjunctivitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Cardiac disorders Atrial fibrillation	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Diarrhoea infectious	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Eye infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Folliculitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Fungal skin infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Gastroenteritis viral	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Hordeolum	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Medical device site infection	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Pharyngitis streptococcal	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Pneumonia	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Cardiac disorders Palpitations	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Rash pustular	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Rhinitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Sinusitis	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Tooth abscess	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Tooth infection	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Upper respiratory tract infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Urinary tract infection	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	15.4% 4/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Vaginal infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Cardiac disorders Supraventricular tachycardia	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Infections and infestations Wound infection	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Contusion	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Fall	7.7% 2/26 • Number of events 3 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Infusion related reaction	11.5% 3/26 • Number of events 5 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	11.5% 3/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/7 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	3.8% 1/26 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Wound complication	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	0.00% 0/26 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Investigations Alanine aminotransferase increased	15.4% 4/26 • Number of events 4 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	14.3% 1/7 • Number of events 1 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.	7.7% 2/26 • Number of events 2 • Part 1: Day 1 through 90 days after the last dose of study drug (approximately 2.8 years); Part 2: Day 1 through 90 days after the last dose of study drug (approximately 2.6 years) As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.

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