Trial Outcomes & Findings for PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma (NCT NCT03269136)

Last Updated: 2025-03-18

Results Overview

Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

101 participants

Primary outcome timeframe

Cycle 1 (21 Days)

Results posted on

2025-03-18

Participant Flow

A total of 101 participants (Part 1: 86 participants and Part 2: 15 participants) were enrolled in the study.

The following parts were planned for the study: Part 1 dose escalation included Part 1 monotherapy, Part 1.1 dose priming, Part 1C lenalidomide combination, Part 1D pomalidomide combination and Part 1E dexamethasone combination. Part 2 dose expansion included Part 2A monotherapy, Part 2C lenalidomide combination, Part 2D pomalidomide combination and Part 2E dexamethasone combination. Participants were not enrolled in Parts 1E, 2C, 2D and 2E and their data is not reported in the record.

Participant milestones

Participant milestones
Measure	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 2A: PF-06863135 SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Dose Escalation STARTED	2	3	2	3	2	5	6	6	4	4	4	6	6	7	13	4	9	0
Part 1: Dose Escalation COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part 1: Dose Escalation NOT COMPLETED	2	3	2	3	2	5	6	6	4	4	4	6	6	7	13	4	9	0
Part 2A: Dose Expansion STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	15
Part 2A: Dose Expansion COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part 2A: Dose Expansion NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 2A: PF-06863135 SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Dose Escalation Other	0	0	0	0	0	0	0	0	0	0	1	1	1	0	3	1	1	0
Part 1: Dose Escalation Refused Further Treatment	0	0	0	0	0	0	1	0	1	0	0	0	1	0	0	0	0	0
Part 1: Dose Escalation Global Deterioration of Health Status	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Part 1: Dose Escalation Lost to Follow-up	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Part 1: Dose Escalation Death	0	0	0	0	0	0	0	0	0	1	0	1	0	1	0	0	2	0
Part 1: Dose Escalation Disease Relapse	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Part 1: Dose Escalation Adverse Event	0	0	0	0	0	0	2	0	0	0	1	2	0	1	0	0	1	0
Part 1: Dose Escalation Progressive Disease	2	3	2	3	2	5	3	5	3	1	2	2	3	3	8	3	4	0
Part 1: Dose Escalation Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	1	2	2	0	1	0
Part 2A: Dose Expansion Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Part 2A: Dose Expansion Refused Further Treatment	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Part 2A: Dose Expansion Disease Relapse	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Part 2A: Dose Expansion Progressive Disease	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	9
Part 2A: Dose Expansion Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2

Baseline Characteristics

PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 2A: PF-06863135 SC n=15 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Total n=101 Participants Total of all reporting groups
Age, Continuous	58.0 Years STANDARD_DEVIATION 4.24 • n=5 Participants	67.3 Years STANDARD_DEVIATION 4.04 • n=7 Participants	53.0 Years STANDARD_DEVIATION 0.00 • n=5 Participants	63.3 Years STANDARD_DEVIATION 9.24 • n=4 Participants	54.5 Years STANDARD_DEVIATION 4.95 • n=21 Participants	70.8 Years STANDARD_DEVIATION 14.15 • n=8 Participants	67.0 Years STANDARD_DEVIATION 8.92 • n=8 Participants	67.3 Years STANDARD_DEVIATION 8.73 • n=24 Participants	63.8 Years STANDARD_DEVIATION 11.64 • n=42 Participants	68.5 Years STANDARD_DEVIATION 9.11 • n=42 Participants	62.0 Years STANDARD_DEVIATION 3.92 • n=42 Participants	59.5 Years STANDARD_DEVIATION 8.31 • n=42 Participants	58.5 Years STANDARD_DEVIATION 11.48 • n=36 Participants	60.0 Years STANDARD_DEVIATION 12.22 • n=36 Participants	67.4 Years STANDARD_DEVIATION 7.26 • n=24 Participants	60.5 Years STANDARD_DEVIATION 22.49 • n=135 Participants	58.9 Years STANDARD_DEVIATION 8.33 • n=136 Participants	66.7 Years STANDARD_DEVIATION 9.65 • n=44 Participants	63.7 Years STANDARD_DEVIATION 10.18 • n=667 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	6 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	5 Participants n=36 Participants	4 Participants n=24 Participants	1 Participants n=135 Participants	3 Participants n=136 Participants	7 Participants n=44 Participants	47 Participants n=667 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=36 Participants	2 Participants n=36 Participants	9 Participants n=24 Participants	3 Participants n=135 Participants	6 Participants n=136 Participants	8 Participants n=44 Participants	54 Participants n=667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	2 Participants n=44 Participants	4 Participants n=667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=36 Participants	7 Participants n=36 Participants	13 Participants n=24 Participants	4 Participants n=135 Participants	8 Participants n=136 Participants	13 Participants n=44 Participants	96 Participants n=667 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	6 Participants n=667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants	2 Participants n=24 Participants	2 Participants n=135 Participants	1 Participants n=136 Participants	1 Participants n=44 Participants	19 Participants n=667 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	5 Participants n=36 Participants	10 Participants n=24 Participants	2 Participants n=135 Participants	8 Participants n=136 Participants	10 Participants n=44 Participants	71 Participants n=667 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	5 Participants n=667 Participants

PRIMARY outcome

Timeframe: Cycle 1 (21 Days)

Population: DLT evaluable set included all participants that had experienced a DLT in the DLT observation period or received all of their planned doses of PF-06863135 in the initial DLT observation period if Q2W dosing was being evaluated or at least all but one of their planned doses of PF-0686135 if Q1W dosing was being evaluated, provided a dose was not missed due to toxicity attributed to study drug.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=14 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)

Population: Modified intent to treat (mITT) analysis set included all participants who have received at least one dose of study treatment.

ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria	—	—	—	—	—	—	—	—	—	60.0 Percentage of participants Interval 35.7 to 80.2	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)

DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum \& urine \& disappearance of any soft tissue plasmacytomas\&\<5% plasma cells in bone marrow aspirates.VGPR: serum \& urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=9 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Duration of Response (DOR) as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	11.6 Months Interval 2.5 to The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)

Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.

AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with AEs	6 Participants	7 Participants	13 Participants	6 Participants	6 Participants	4 Participants	4 Participants	4 Participants	9 Participants	2 Participants	3 Participants	2 Participants	3 Participants	2 Participants	5 Participants	4 Participants	6 Participants	23 Participants	30 Participants	20 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with serious TEAEs	5 Participants	6 Participants	9 Participants	5 Participants	4 Participants	1 Participants	3 Participants	2 Participants	8 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	2 Participants	3 Participants	4 Participants	11 Participants	20 Participants	15 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with treatment related AEs	6 Participants	7 Participants	13 Participants	6 Participants	4 Participants	4 Participants	4 Participants	4 Participants	9 Participants	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	4 Participants	4 Participants	6 Participants	17 Participants	28 Participants	20 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with grade 3 or 4 AEs	6 Participants	3 Participants	12 Participants	6 Participants	3 Participants	4 Participants	3 Participants	4 Participants	7 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants	3 Participants	4 Participants	4 Participants	17 Participants	24 Participants	15 Participants
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with grade 5 AEs	0 Participants	3 Participants	1 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)

Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.

Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters	6 Participants	6 Participants	13 Participants	5 Participants	6 Participants	3 Participants	4 Participants	4 Participants	9 Participants	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants	5 Participants	4 Participants	6 Participants	19 Participants	29 Participants	19 Participants

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)

Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.

Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters	2 Participants	3 Participants	8 Participants	1 Participants	2 Participants	0 Participants	2 Participants	4 Participants	3 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	2 Participants	3 Participants	6 Participants	11 Participants	11 Participants

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)

Population: Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.

Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: ORR as Per IMWG Criteria	83.3 Percentage of participants Interval 43.6 to 97.0	57.1 Percentage of participants Interval 25.0 to 84.2	61.5 Percentage of participants Interval 25.5 to 82.3	0 Percentage of participants Interval 0.0 to 39.0	0 Percentage of participants Interval 0.0 to 39.0	0 Percentage of participants Interval 0.0 to 49.0	50.0 Percentage of participants Interval 15.0 to 85.0	75.0 Percentage of participants Interval 30.1 to 95.4	77.8 Percentage of participants Interval 45.3 to 93.7	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 56.1	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 56.1	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 43.4	75.0 Percentage of participants Interval 30.1 to 95.4	66.7 Percentage of participants Interval 30.0 to 90.3	0 Percentage of participants Interval 0.0 to 14.3	46.7 Percentage of participants Interval 30.2 to 63.9	60.0 Percentage of participants Interval 38.7 to 78.1

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with confirmed objective response.

TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum\& urine \& disappearance of soft tissue plasmacytomas \& \<5% plasma cells in bone marrow aspirates. VGPR: serum\& urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein\& reduction in 24hrs urinary M-protein by \>=90% or \<200 mg/24hr. If serum \& urine M-protein unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=8 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=14 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=12 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Time to Response (TTR) as Per IMWG Criteria	42.0 Days Interval 22.0 to 92.0	39.0 Days Interval 8.0 to 65.0	36.0 Days Interval 7.0 to 73.0	—	—	—	22.0 Days Interval 22.0 to 22.0	52.0 Days Interval 8.0 to 281.0	50.0 Days Interval 7.0 to 105.0	—	—	—	—	—	—	22.0 Days Interval 22.0 to 24.0	22.0 Days Interval 21.0 to 23.0	—	22.0 Days Interval 21.0 to 92.0	36.0 Days Interval 7.0 to 73.0

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Complete Response Rate (CRR) as Per IMWG Criteria	50.0 Percentage of participants Interval 18.8 to 81.2	14.3 Percentage of participants Interval 2.6 to 51.3	46.2 Percentage of participants Interval 23.2 to 70.9	0 Percentage of participants Interval 0.0 to 39.0	0 Percentage of participants Interval 0.0 to 39.0	0 Percentage of participants Interval 0.0 to 49.0	50.0 Percentage of participants Interval 15.0 to 85.0	50.0 Percentage of participants Interval 15.0 to 85.0	33.3 Percentage of participants Interval 12.1 to 64.6	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 56.1	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 56.1	0 Percentage of participants Interval 0.0 to 65.8	0 Percentage of participants Interval 0.0 to 43.4	25.0 Percentage of participants Interval 4.6 to 69.9	50.0 Percentage of participants Interval 18.8 to 81.2	0 Percentage of participants Interval 0.0 to 14.3	30.0 Percentage of participants Interval 16.7 to 47.9	35.0 Percentage of participants Interval 18.1 to 56.7

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=8 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=14 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=12 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: DOR as Per IMWG Criteria	NA Months Interval 6.3 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	6.7 Months Interval 3.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	17.1 Months Interval 10.6 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	—	—	25.3 Months Interval 18.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	14.9 Months Interval 11.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	8.3 Months Interval 2.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—	13.6 Months Interval 5.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 32.2 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	32.2 Months Interval 7.0 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	13.3 Months Interval 6.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)

DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=1 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=1 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria	NA Months Interval 7.0 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.9 months.	NA Months Interval 6.5 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events	—	—	—	25.3 Months Interval 18.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 10.3 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 3.7 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—	NA Months Median and CI could not be reported as participant did not have event.	NA Months Only one participant had event, hence median and CI not reported. Individual participant data was 31.5 months.	—	31.5 Months Interval 7.0 to The upper limit of 95% CI was not estimable due to low number of participants with events.	11.5 Months Interval 1.9 to The upper limit of 95% CI was not estimable due to low number of participants with events.

SECONDARY outcome

Timeframe: Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arm where it is "0" signifies there was no participant with stable disease.

DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum \& urine \&disappearance of any soft tissue plasmacytomas \&\<5% plasma cells in bone marrow aspirates. VGPR: serum \& urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hours urinary Mp by \>=90% or\<200 mg/24 hr. If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=1 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=1 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=15 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria	NA Months Interval 7.0 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	7.4 Months Interval 3.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	17.6 Months Interval 11.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	3.0 Months Interval 2.2 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	0.4 Months Interval 0.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	0.6 Months Interval 0.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	18.4 Months Interval 4.2 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	17.9 Months Interval 1.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	5.6 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	1.3 Months Interval 0.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 0.7 months.	0.8 Months Interval 0.6 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.8 months.	3.4 Months Interval 1.0 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	13.6 Months Interval 5.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	32.2 Months Interval 2.1 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.8 Months Interval 0.6 to 3.4	7.3 Months Interval 1.4 to 32.3	12.0 Months Interval 7.4 to 20.2

SECONDARY outcome

Timeframe: From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Progression Free Survival (PFS) as Per IMWG Criteria	8.0 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	7.6 Months Interval 3.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	12.7 Months Interval 0.5 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	2.9 Months Interval 0.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.0 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.0 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	19.1 Months Interval 4.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	18.1 Months Interval 1.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	6.7 Months Interval 0.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	0.4 Months Interval 0.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	0.7 Months Interval 0.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.1 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.7 Months Interval 0.6 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.6 Months Interval 0.6 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.6 Months Interval 0.6 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	10.2 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	32.9 Months Interval 0.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.4 Months Interval 0.6 to 2.6	4.8 Months Interval 1.1 to 14.4	12.2 Months Interval 3.9 to 19.2

SECONDARY outcome

Timeframe: Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 63.31 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Overall Survival (OS)	NA Months Interval 2.2 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	8.3 Months Interval 3.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 1.1 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	18.0 Months Interval 5.0 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	1.7 Months Interval 0.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 3.8 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.	19.1 Months Interval 8.8 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	31.3 Months Interval 28.3 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	NA Months Interval 5.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	8.2 Months Interval 4.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	8.4 Months Interval 1.9 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	11.2 Months Interval 4.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	8.1 Months Interval 1.7 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	16.2 Months Interval 9.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	14.8 Months Interval 2.4 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	14.0 Months Interval 3.0 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	32.9 Months Interval 12.0 to The upper limit of 95% CI was not estimable due to insufficient number of participants with events.	12.0 Months Interval 7.9 to 17.1	17.3 Months Interval 6.2 to 44.8	NA Months Interval 5.4 to The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first (maximum up to 63.31 months)

Population: Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.

MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10\^-5 and 10\^-6.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 Participants Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria 10^-5 threshold MRD	16.67 Percentage of participants	28.57 Percentage of participants	38.46 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	50.00 Percentage of participants	25.00 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	16.67 Percentage of participants	0 Percentage of participants	13.33 Percentage of participants	35.00 Percentage of participants
Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria 10^-6 threshold MRD	16.67 Percentage of participants	0 Percentage of participants	30.77 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	25.00 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	16.67 Percentage of participants	0 Percentage of participants	10.00 Percentage of participants	20.00 Percentage of participants

SECONDARY outcome

Timeframe: 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2

Population: Pharmacokinetic (PK) parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.

Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=12 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Total PF-06863135: Cycle 0 Day 1	—	3.639 Micrograms per milliliter Geometric Coefficient of Variation 21	4.216 Micrograms per milliliter Geometric Coefficient of Variation 42	—	—	—	—	2.144 Micrograms per milliliter Geometric Coefficient of Variation 96	2.277 Micrograms per milliliter Geometric Coefficient of Variation 51	—	—	—	—	—	—	—	—	—	—	—
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Total PF-06863135: Cycle 1 Day 1	3.620 Micrograms per milliliter Geometric Coefficient of Variation 53	9.927 Micrograms per milliliter Geometric Coefficient of Variation 18	8.710 Micrograms per milliliter Geometric Coefficient of Variation 54	0.8725 Micrograms per milliliter Geometric Coefficient of Variation 41	0.2866 Micrograms per milliliter Geometric Coefficient of Variation 46	0.9076 Micrograms per milliliter Geometric Coefficient of Variation 24	1.220 Micrograms per milliliter Geometric Coefficient of Variation 25	5.513 Micrograms per milliliter Geometric Coefficient of Variation 141	5.814 Micrograms per milliliter Geometric Coefficient of Variation 36	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00168 and 0.00282.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00287 and 0.00439	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0122 and 0.0133.	0.05363 Micrograms per milliliter Geometric Coefficient of Variation 36	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.164 and 0.297.	0.6044 Micrograms per milliliter Geometric Coefficient of Variation 27	2.568 Micrograms per milliliter Geometric Coefficient of Variation 42	3.802 Micrograms per milliliter Geometric Coefficient of Variation 12	—	—	—
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Total PF-06863135: Cycle 2 Day 1	12.98 Micrograms per milliliter Geometric Coefficient of Variation 26	25.74 Micrograms per milliliter Geometric Coefficient of Variation 19	12.03 Micrograms per milliliter Geometric Coefficient of Variation 67	1.684 Micrograms per milliliter Geometric Coefficient of Variation 23	0.6904 Micrograms per milliliter Geometric Coefficient of Variation 55	2.108 Micrograms per milliliter Geometric Coefficient of Variation 38	3.021 Micrograms per milliliter Geometric Coefficient of Variation 24	NA Micrograms per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 16.6.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 10.8 and 12.0.	—	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.475 and 0.624.	NA Micrograms per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.219.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.151 and 0.233.	NA Micrograms per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.440.	0.9924 Micrograms per milliliter Geometric Coefficient of Variation 8	5.748 Micrograms per milliliter Geometric Coefficient of Variation 16	11.92 Micrograms per milliliter Geometric Coefficient of Variation 28	—	—	—
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Free PF-06863135: Cycle 1 Day 1	0.8266 Micrograms per milliliter Geometric Coefficient of Variation 66	2.088 Micrograms per milliliter Geometric Coefficient of Variation 106	2.485 Micrograms per milliliter Geometric Coefficient of Variation 91	0.3015 Micrograms per milliliter Geometric Coefficient of Variation 75	0.09913 Micrograms per milliliter Geometric Coefficient of Variation 36	0.2479 Micrograms per milliliter Geometric Coefficient of Variation 28	0.5916 Micrograms per milliliter Geometric Coefficient of Variation 47	1.185 Micrograms per milliliter Geometric Coefficient of Variation 90	2.150 Micrograms per milliliter Geometric Coefficient of Variation 76	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	0.0008828 Micrograms per milliliter Geometric Coefficient of Variation 1.23	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0760 and 0.153.	0.1851 Micrograms per milliliter Geometric Coefficient of Variation 40	0.8304 Micrograms per milliliter Geometric Coefficient of Variation 131	0.9875 Micrograms per milliliter Geometric Coefficient of Variation 52	—	—	—
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Free PF-06863135: Cycle 2 Day 1	3.953 Micrograms per milliliter Geometric Coefficient of Variation 156	11.00 Micrograms per milliliter Geometric Coefficient of Variation 186	5.323 Micrograms per milliliter Geometric Coefficient of Variation 69	0.2955 Micrograms per milliliter Geometric Coefficient of Variation 4	0.1794 Micrograms per milliliter Geometric Coefficient of Variation 40	0.3998 Micrograms per milliliter Geometric Coefficient of Variation 41	1.473 Micrograms per milliliter Geometric Coefficient of Variation 79	NA Micrograms per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 2.53.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 9.65 and 12.1.	—	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Micrograms per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Micrograms per milliliter Geometric Coefficient of Variation NA Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.103.	0.2855 Micrograms per milliliter Geometric Coefficient of Variation 37	1.605 Micrograms per milliliter Geometric Coefficient of Variation 182	7.981 Micrograms per milliliter Geometric Coefficient of Variation 79	—	—	—
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135 Free PF-06863135: Cycle 0 Day 1	—	0.9445 Micrograms per milliliter Geometric Coefficient of Variation 59	1.087 Micrograms per milliliter Geometric Coefficient of Variation 79	—	—	—	—	0.5165 Micrograms per milliliter Geometric Coefficient of Variation 83	0.8080 Micrograms per milliliter Geometric Coefficient of Variation 59	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2

Population: PK parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.

Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=12 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Total PF-06863135: Cycle 1 Day 1	25.53 Microgram*day per milliliter Geometric Coefficient of Variation 36	58.93 Microgram*day per milliliter Geometric Coefficient of Variation 14	93.96 Microgram*day per milliliter Geometric Coefficient of Variation 53	3.322 Microgram*day per milliliter Geometric Coefficient of Variation 40	1.182 Microgram*day per milliliter Geometric Coefficient of Variation 58	4.426 Microgram*day per milliliter Geometric Coefficient of Variation 17	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.35 and 6.09.	54.78 Microgram*day per milliliter Geometric Coefficient of Variation 16	31.92 Microgram*day per milliliter Geometric Coefficient of Variation 45	NA Microgram*day per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.00829.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00933 and 0.0136.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0483 and 0.0484.	0.1654 Microgram*day per milliliter Geometric Coefficient of Variation 74	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.763 and 0.877.	2.190 Microgram*day per milliliter Geometric Coefficient of Variation 11	12.58 Microgram*day per milliliter Geometric Coefficient of Variation 26	17.92 Microgram*day per milliliter Geometric Coefficient of Variation 29	—	—	—
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Total PF-06863135: Cycle 2 Day 1	88.92 Microgram*day per milliliter Geometric Coefficient of Variation 31	173.4 Microgram*day per milliliter Geometric Coefficient of Variation 21	148.1 Microgram*day per milliliter Geometric Coefficient of Variation 65	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 7.91 and 8.10.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.77 and 10.1.	13.47 Microgram*day per milliliter Geometric Coefficient of Variation 39	—	—	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 71.7 and 77.8.	—	NA Microgram*day per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0276.	NA Microgram*day per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0790.	—	—	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.88 and 4.36.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 32.2 and 42.2.	76.83 Microgram*day per milliliter Geometric Coefficient of Variation 30	—	—	—
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Free PF-06863135: Cycle 2 Day 1	34.18 Microgram*day per milliliter Geometric Coefficient of Variation 155	45.63 Microgram*day per milliliter Geometric Coefficient of Variation 128	66.20 Microgram*day per milliliter Geometric Coefficient of Variation 63	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 1.51 and 1.57.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 2.15.	2.572 Microgram*day per milliliter Geometric Coefficient of Variation 49	—	—	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 64.2 and 71.2.	—	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Microgram*day per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Microgram*day per milliliter Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.	0.05280 Microgram*day per milliliter Geometric Coefficient of Variation 2.59	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.43 and 6.57.	45.14 Microgram*day per milliliter Geometric Coefficient of Variation 113	—	—	—
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Total PF-06863135: Cycle 0 Day 1	—	16.82 Microgram*day per milliliter Geometric Coefficient of Variation 20	16.93 Microgram*day per milliliter Geometric Coefficient of Variation 46	—	—	—	—	9.643 Microgram*day per milliliter Geometric Coefficient of Variation 148	10.91 Microgram*day per milliliter Geometric Coefficient of Variation 37	—	—	—	—	—	—	—	—	—	—	—
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Free PF-06863135: Cycle 0 Day 1	—	4.111 Microgram*day per milliliter Geometric Coefficient of Variation 49	5.054 Microgram*day per milliliter Geometric Coefficient of Variation 73	—	—	—	—	2.447 Microgram*day per milliliter Geometric Coefficient of Variation 92	3.487 Microgram*day per milliliter Geometric Coefficient of Variation 50	—	—	—	—	—	—	—	—	—	—	—
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau) Free PF-06863135: Cycle 1 Day 1	6.564 Microgram*day per milliliter Geometric Coefficient of Variation 33	11.92 Microgram*day per milliliter Geometric Coefficient of Variation 109	34.13 Microgram*day per milliliter Geometric Coefficient of Variation 60	1.206 Microgram*day per milliliter Geometric Coefficient of Variation 62	0.3344 Microgram*day per milliliter Geometric Coefficient of Variation 72	1.478 Microgram*day per milliliter Geometric Coefficient of Variation 23	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 2.67 and 3.29.	8.896 Microgram*day per milliliter Geometric Coefficient of Variation 12	11.40 Microgram*day per milliliter Geometric Coefficient of Variation 91	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.	0.0009462 Microgram*day per milliliter Geometric Coefficient of Variation 1.95	NA Microgram*day per milliliter Geometric Coefficient of Variation NA Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.261 and 0.618.	0.7801 Microgram*day per milliliter Geometric Coefficient of Variation 24	4.362 Microgram*day per milliliter Geometric Coefficient of Variation 103	4.909 Microgram*day per milliliter Geometric Coefficient of Variation 42	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)

Population: PK Concentration Analysis Set was defined as all participants randomized and treated who had at least 1 measurable PF-06863135 concentration.

Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=4 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide Cycle 1 Day 1	—	—	—	—	—	—	—	—	—	NA nanogram/milliliter Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).	NA nanogram/milliliter Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).	—	—	—	—	—	—	—	—	—
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide Cycle 1 Day 8	—	—	—	—	—	—	—	—	—	70.70 nanogram/milliliter Interval 70.7 to 70.7	13.60 nanogram/milliliter Interval 0.0 to 57.8	—	—	—	—	—	—	—	—	—
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide Cycle 1 Day 15	—	—	—	—	—	—	—	—	—	70.60 nanogram/milliliter Interval 70.6 to 70.6	32.70 nanogram/milliliter Interval 0.0 to 49.1	—	—	—	—	—	—	—	—	—
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide Cycle 2 Day 15	—	—	—	—	—	—	—	—	—	36.70 nanogram/milliliter Interval 20.2 to 234.0	0.0000 nanogram/milliliter Interval 0.0 to 7.41	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)

Population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 ADA positive	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	—	—	—
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135 NAb positive	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Part 1: C1 (0, 2, 4 & 8 hours [h] post dose on Day [D] 1, 24h post dose on D2, 72h post dose on D3); Part 1.1, 1C & 1D: C0 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2); C1 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2, 72h post dose on D3)

Population: The Pharmacodynamic (PD)/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. Here, "Number Analyzed" signifies participants evaluable for specified rows.

The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. Cycle = C.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 Participants Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 0 hours	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 2 hours	—	2.10 Picogram per milliliter Interval 2.1 to 9.1	2.10 Picogram per milliliter Interval 2.1 to 55.0	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 10.5	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 4 hours	—	2.70 Picogram per milliliter Interval 2.1 to 19.7	3.60 Picogram per milliliter Interval 2.1 to 247.4	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 6.5	2.40 Picogram per milliliter Interval 2.1 to 20.9	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 8 hours	—	14.30 Picogram per milliliter Interval 2.1 to 487.8	17.90 Picogram per milliliter Interval 2.1 to 118.1	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 82.0	2.10 Picogram per milliliter Interval 2.1 to 1063.8	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 24 hours	—	2.10 Picogram per milliliter Interval 2.1 to 12.2	2.10 Picogram per milliliter Interval 2.1 to 15.5	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.3	2.10 Picogram per milliliter Interval 2.1 to 7.1	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 0 hours	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 37.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 24.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 2.1 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 2 hours	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	12.50 Picogram per milliliter Interval 5.0 to 112.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 2.1 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 4 hours	2.10 Picogram per milliliter Interval 2.1 to 34.9	2.10 Picogram per milliliter Interval 2.1 to 2.2	2.10 Picogram per milliliter Interval 2.1 to 2.1	83.00 Picogram per milliliter Interval 21.0 to 202.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.50 Picogram per milliliter Interval 5.0 to 6.0	53.00 Picogram per milliliter Interval 5.0 to 80.0	5.50 Picogram per milliliter Interval 5.0 to 7.0	5.00 Picogram per milliliter Interval 2.1 to 6.7	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 8 hours	2.10 Picogram per milliliter Interval 2.1 to 55.7	2.10 Picogram per milliliter Interval 2.1 to 18.3	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 52.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 50.0	8.50 Picogram per milliliter Interval 5.0 to 15.0	2.10 Picogram per milliliter Interval 2.1 to 2.4	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	11.0 Picogram per milliliter Interval 5.0 to 43.0	12.50 Picogram per milliliter Interval 5.0 to 39.0	5.00 Picogram per milliliter Interval 2.1 to 20.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 24 hours	2.10 Picogram per milliliter Interval 2.1 to 5.8	2.10 Picogram per milliliter Interval 2.1 to 2.7	2.10 Picogram per milliliter Interval 2.1 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.10 Picogram per milliliter Interval 2.1 to 7.4	2.10 Picogram per milliliter Interval 2.1 to 7.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 9.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 2.1 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 72 hours	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	2.10 Picogram per milliliter Interval 2.1 to 2.1	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.10 Picogram per milliliter Interval 2.1 to 4.7	2.10 Picogram per milliliter Interval 2.1 to 3.5	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 14.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 2.1 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 0 hours	2.00 Picogram per milliliter Interval 2.0 to 28.1	59.20 Picogram per milliliter Interval 9.6 to 370.9	24.50 Picogram per milliliter Interval 2.1 to 212.3	5.00 Picogram per milliliter Interval 5.0 to 7.0	5.00 Picogram per milliliter Interval 5.0 to 32.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	9.30 Picogram per milliliter Interval 2.0 to 219.5	2.00 Picogram per milliliter Interval 2.0 to 146.8	7.00 Picogram per milliliter Interval 5.0 to 9.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	6.50 Picogram per milliliter Interval 5.0 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 32.0	6.50 Picogram per milliliter Interval 5.0 to 23.0	5.00 Picogram per milliliter Interval 2.0 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 2 hours	2.00 Picogram per milliliter Interval 2.0 to 151.6	56.45 Picogram per milliliter Interval 7.7 to 205.1	20.60 Picogram per milliliter Interval 2.7 to 150.5	9.50 Picogram per milliliter Interval 5.0 to 56.0	5.00 Picogram per milliliter Interval 5.0 to 43.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	8.05 Picogram per milliliter Interval 2.0 to 278.8	2.30 Picogram per milliliter Interval 2.0 to 200.5	6.00 Picogram per milliliter Interval 5.0 to 7.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	17.00 Picogram per milliliter Interval 5.0 to 29.0	5.00 Picogram per milliliter Interval 5.0 to 14.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 29.0	6.50 Picogram per milliliter Interval 5.0 to 20.0	5.00 Picogram per milliliter Interval 2.0 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 4 hours	8.95 Picogram per milliliter Interval 2.0 to 20.0	58.70 Picogram per milliliter Interval 5.5 to 303.8	22.95 Picogram per milliliter Interval 3.2 to 187.4	73.00 Picogram per milliliter Interval 15.0 to 813.0	5.00 Picogram per milliliter Interval 5.0 to 54.0	5.00 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 5.0 to 7.0	7.45 Picogram per milliliter Interval 2.0 to 292.6	2.25 Picogram per milliliter Interval 2.0 to 165.0	6.50 Picogram per milliliter Interval 5.0 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	7.00 Picogram per milliliter Interval 5.0 to 9.0	5.00 Picogram per milliliter Interval 5.0 to 16.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	106.00 Picogram per milliliter Interval 5.0 to 206.0	15.50 Picogram per milliliter Interval 5.0 to 71.0	5.00 Picogram per milliliter Interval 3.5 to 21.7	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 8 hours	24.85 Picogram per milliliter Interval 2.0 to 2080.9	52.50 Picogram per milliliter Interval 6.9 to 125.1	35.00 Picogram per milliliter Interval 5.1 to 174.8	25.00 Picogram per milliliter Interval 5.0 to 263.0	5.00 Picogram per milliliter Interval 5.0 to 33.0	8.00 Picogram per milliliter Interval 5.0 to 54.0	46.50 Picogram per milliliter Interval 5.0 to 67.0	12.80 Picogram per milliliter Interval 2.0 to 634.1	2.00 Picogram per milliliter Interval 2.0 to 621.5	5.50 Picogram per milliliter Interval 5.0 to 6.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	6.50 Picogram per milliliter Interval 5.0 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	40.00 Picogram per milliliter Interval 5.0 to 327.0	184.50 Picogram per milliliter Interval 12.0 to 342.0	12.00 Picogram per milliliter Interval 5.0 to 33.6	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 24 hours	31.25 Picogram per milliliter Interval 2.3 to 250.0	129.65 Picogram per milliliter Interval 10.5 to 631.3	38.35 Picogram per milliliter Interval 3.5 to 250.3	6.00 Picogram per milliliter Interval 5.0 to 18.0	7.00 Picogram per milliliter Interval 5.0 to 64.0	9.00 Picogram per milliliter Interval 5.0 to 13.0	16.50 Picogram per milliliter Interval 6.0 to 51.0	12.15 Picogram per milliliter Interval 2.0 to 577.6	2.90 Picogram per milliliter Interval 2.0 to 78.7	7.00 Picogram per milliliter Interval 5.0 to 9.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	8.00 Picogram per milliliter Interval 5.0 to 11.0	5.00 Picogram per milliliter Interval 5.0 to 163.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 45.0	29.00 Picogram per milliliter Interval 13.0 to 209.0	21.50 Picogram per milliliter Interval 5.0 to 976.8	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 0 hours	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 2 hours	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 4 hours	—	4.20 Picogram per milliliter Interval 4.2 to 13.8	4.20 Picogram per milliliter Interval 2.2 to 18.3	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 12.8	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 8 hours	—	10.30 Picogram per milliliter Interval 4.2 to 487.8	7.20 Picogram per milliliter Interval 4.2 to 34.6	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 26.3	4.20 Picogram per milliliter Interval 4.2 to 106.1	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 24 hours	—	5.00 Picogram per milliliter Interval 4.2 to 28.4	7.40 Picogram per milliliter Interval 4.2 to 17.4	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 25.6	4.20 Picogram per milliliter Interval 4.2 to 23.1	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 2 hours	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	4.20 Picogram per milliliter Interval 4.2 to 4.9	4.20 Picogram per milliliter Interval 4.2 to 7.3	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 4.2 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 4 hours	4.20 Picogram per milliliter Interval 4.2 to 19.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	10.00 Picogram per milliliter Interval 5.0 to 33.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 5.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	9.00 Picogram per milliliter Interval 5.0 to 13.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 4.2 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 8 hours	4.20 Picogram per milliliter Interval 4.2 to 56.9	4.20 Picogram per milliliter Interval 4.2 to 5.5	4.20 Picogram per milliliter Interval 4.2 to 4.2	5.00 Picogram per milliliter Interval 5.0 to 16.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.50 Picogram per milliliter Interval 5.0 to 8.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 7.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	8.50 Picogram per milliliter Interval 5.0 to 39.0	5.50 Picogram per milliliter Interval 5.0 to 22.0	5.00 Picogram per milliliter Interval 4.2 to 6.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 24 hours	4.20 Picogram per milliliter Interval 4.2 to 5.9	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	7.00 Picogram per milliliter Interval 5.0 to 12.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 20.4	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 9.0	5.00 Picogram per milliliter Interval 5.0 to 20.0	5.00 Picogram per milliliter Interval 5.0 to 12.1	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 72 hours	4.20 Picogram per milliliter Interval 0.4 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 8.4	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 4.2 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 4 hours	—	3.30 Picogram per milliliter Interval 1.7 to 27.7	2.50 Picogram per milliliter Interval 1.7 to 164.2	—	—	—	—	2.60 Picogram per milliliter Interval 1.7 to 9.7	1.70 Picogram per milliliter Interval 1.7 to 8.9	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 8 hours	—	9.70 Picogram per milliliter Interval 1.7 to 46.2	7.40 Picogram per milliliter Interval 1.7 to 39.2	—	—	—	—	3.05 Picogram per milliliter Interval 1.7 to 39.1	1.75 Picogram per milliliter Interval 1.7 to 114.2	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 24 hours	—	3.80 Picogram per milliliter Interval 1.7 to 9.1	3.80 Picogram per milliliter Interval 1.7 to 15.1	—	—	—	—	3.15 Picogram per milliliter Interval 1.7 to 4.2	2.30 Picogram per milliliter Interval 1.7 to 8.5	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 0 hours	1.70 Picogram per milliliter Interval 1.7 to 18.4	1.70 Picogram per milliliter Interval 1.7 to 2.2	1.70 Picogram per milliliter Interval 1.7 to 10.3	5.00 Picogram per milliliter Interval 5.0 to 25.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	3.15 Picogram per milliliter Interval 1.7 to 4.6	1.70 Picogram per milliliter Interval 1.7 to 3.3	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 41.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 37.0	5.00 Picogram per milliliter Interval 1.7 to 16.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 2 hours	1.70 Picogram per milliliter Interval 1.7 to 25.5	1.70 Picogram per milliliter Interval 1.7 to 1.7	1.80 Picogram per milliliter Interval 1.7 to 14.7	8.50 Picogram per milliliter Interval 5.0 to 21.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.55 Picogram per milliliter Interval 1.7 to 4.1	1.70 Picogram per milliliter Interval 1.7 to 6.5	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 1.7 to 15.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 4 hours	1.70 Picogram per milliliter Interval 1.7 to 147.3	1.70 Picogram per milliliter Interval 1.7 to 2.7	1.70 Picogram per milliliter Interval 1.7 to 6.3	8.00 Picogram per milliliter Interval 5.0 to 138.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	2.80 Picogram per milliliter Interval 1.7 to 4.0	1.70 Picogram per milliliter Interval 1.7 to 4.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	11.0 Picogram per milliliter Interval 5.0 to 70.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 1.7 to 12.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 8 hours	1.70 Picogram per milliliter Interval 1.7 to 458.0	1.70 Picogram per milliliter Interval 1.7 to 1.9	1.70 Picogram per milliliter Interval 1.7 to 11.6	5.00 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 6.0	6.50 Picogram per milliliter Interval 5.0 to 35.0	1.70 Picogram per milliliter Interval 1.7 to 5.3	1.70 Picogram per milliliter Interval 1.4 to 5.8	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 6.0	8.00 Picogram per milliliter Interval 5.0 to 11.0	5.00 Picogram per milliliter Interval 1.7 to 27.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 24 hours	1.70 Picogram per milliliter Interval 1.7 to 2.0	1.70 Picogram per milliliter Interval 1.7 to 2.1	2.45 Picogram per milliliter Interval 1.7 to 8.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 7.0	2.90 Picogram per milliliter Interval 1.7 to 4.1	1.70 Picogram per milliliter Interval 1.7 to 6.2	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 1.7 to 9.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 72 hours	1.70 Picogram per milliliter Interval 1.7 to 3.4	1.70 Picogram per milliliter Interval 1.7 to 4.2	1.70 Picogram per milliliter Interval 1.7 to 6.7	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 10.0	3.85 Picogram per milliliter Interval 1.7 to 6.9	1.70 Picogram per milliliter Interval 1.7 to 3.6	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 15.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 1.7 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 0 hours	—	2.00 Picogram per milliliter Interval 2.0 to 4.9	2.00 Picogram per milliliter Interval 2.0 to 17.4	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 2.9	2.00 Picogram per milliliter Interval 2.0 to 2.5	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 2 hours	—	2.10 Picogram per milliliter Interval 2.0 to 10.8	2.00 Picogram per milliliter Interval 2.0 to 60.5	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 3.6	2.00 Picogram per milliliter Interval 2.0 to 2.2	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 4 hours	—	11.50 Picogram per milliliter Interval 3.2 to 63.6	10.40 Picogram per milliliter Interval 2.0 to 843.7	—	—	—	—	3.75 Picogram per milliliter Interval 2.0 to 17.1	5.25 Picogram per milliliter Interval 2.0 to 88.5	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 8 hours	—	88.40 Picogram per milliliter Interval 14.8 to 1821.1	129.90 Picogram per milliliter Interval 2.0 to 1028.0	—	—	—	—	3.70 Picogram per milliliter Interval 2.2 to 670.4	2.00 Picogram per milliliter Interval 2.0 to 169.8	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 24 hours	—	201.40 Picogram per milliliter Interval 15.1 to 428.4	122.70 Picogram per milliliter Interval 2.6 to 2396.8	—	—	—	—	8.50 Picogram per milliliter Interval 5.3 to 1651.0	33.60 Picogram per milliliter Interval 4.7 to 882.2	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 72 hours	7.20 Picogram per milliliter Interval 2.0 to 45.1	89.20 Picogram per milliliter Interval 11.1 to 161.3	30.45 Picogram per milliliter Interval 2.0 to 170.4	5.00 Picogram per milliliter Interval 5.0 to 11.0	10.00 Picogram per milliliter Interval 5.0 to 13.0	6.00 Picogram per milliliter Interval 5.0 to 9.0	10.50 Picogram per milliliter Interval 5.0 to 74.0	12.25 Picogram per milliliter Interval 2.0 to 188.3	32.75 Picogram per milliliter Interval 2.0 to 1239.3	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	8.50 Picogram per milliliter Interval 5.0 to 12.0	5.00 Picogram per milliliter Interval 5.0 to 56.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	7.00 Picogram per milliliter Interval 5.0 to 37.0	11.0 Picogram per milliliter Interval 5.0 to 946.0	18.50 Picogram per milliliter Interval 5.0 to 224.2	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 0 hours	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 4.2	5.00 Picogram per milliliter Interval 5.0 to 164.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	4.20 Picogram per milliliter Interval 4.2 to 4.2	4.20 Picogram per milliliter Interval 4.2 to 5.9	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 5.0 to 7.0	5.00 Picogram per milliliter Interval 5.0 to 5.0	5.00 Picogram per milliliter Interval 4.2 to 5.0	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 0 hours	—	1.70 Picogram per milliliter Interval 1.7 to 1.7	1.70 Picogram per milliliter Interval 1.7 to 17.7	—	—	—	—	2.00 Picogram per milliliter Interval 1.7 to 2.3	1.70 Picogram per milliliter Interval 1.7 to 1.7	—	—	—	—	—	—	—	—	—	—	—
Part 1: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 2 hours	—	1.70 Picogram per milliliter Interval 1.7 to 2.8	1.70 Picogram per milliliter Interval 1.7 to 75.6	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 3.5	2.35 Picogram per milliliter Interval 1.7 to 6.2	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with treatment related AEs	—	—	—	—	—	—	—	—	—	13 Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with grade 3 or 4 AEs	—	—	—	—	—	—	—	—	—	11 Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with grade 5 AEs	—	—	—	—	—	—	—	—	—	3 Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with TEAEs	—	—	—	—	—	—	—	—	—	15 Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03 Participants with serious AEs	—	—	—	—	—	—	—	—	—	12 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters	—	—	—	—	—	—	—	—	—	15 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters	—	—	—	—	—	—	—	—	—	8 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)

Population: Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis	—	—	—	—	—	—	—	—	—	0 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: CRR as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	33.3 Percentage of participants Interval 15.2 to 58.3	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 34.3 months)

DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=5 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: DoCR as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	9.4 Months Interval 6.5 to Upper limit of 95% CI was not estimable due to insufficient number of participants with event.	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=9 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: TTR as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	40.0 Days Interval 8.0 to 262.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=12 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: DOSD as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	11.6 Months Interval 1.9 to Upper limit of 95% CI was not estimable due to insufficient number of participants with event.	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 34.3 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: PFS as Per IMWG Criteria	—	—	—	—	—	—	—	—	—	10.4 Months Interval 1.2 to 20.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)

Population: mITT analysis set included all participants who have received at least one dose of study treatment.

OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: OS	—	—	—	—	—	—	—	—	—	12.1 Months Interval 4.2 to Upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)

Population: Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria 10^-5 threshold MRD	—	—	—	—	—	—	—	—	—	33.33 Percentage of Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria 10^-6 threshold MRD	—	—	—	—	—	—	—	—	—	13.33 Percentage of Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)

Population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Number of Participants With ADA and NAb Against PF-06863135 ADA positive	—	—	—	—	—	—	—	—	—	0 Participants	—	—	—	—	—	—	—	—	—	—
Part 2: Number of Participants With ADA and NAb Against PF-06863135 NAb positive	—	—	—	—	—	—	—	—	—	0 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)

Population: The PD/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.

The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1: PF-06863135 1000 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.1 mcg/kg IV n=15 Participants Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 0 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 2 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 27.5	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 4 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 48.6	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 8 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 10.6	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 0; 24 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 30.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 0 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 2 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 4 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 8 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 3.0	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 24 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-2: Cycle 1; 72 hours	—	—	—	—	—	—	—	—	—	2.10 Picogram per milliliter Interval 2.1 to 2.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 0 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 63.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 2 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 7.0	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 4 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 23.1	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 8 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 9.3	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 0; 24 hours	—	—	—	—	—	—	—	—	—	10.30 Picogram per milliliter Interval 2.0 to 2480.3	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 0 hours	—	—	—	—	—	—	—	—	—	5.05 Picogram per milliliter Interval 2.0 to 156.0	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 2 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 88.6	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 4 hours	—	—	—	—	—	—	—	—	—	2.30 Picogram per milliliter Interval 2.0 to 78.9	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 8 hours	—	—	—	—	—	—	—	—	—	2.00 Picogram per milliliter Interval 2.0 to 53.3	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 24 hours	—	—	—	—	—	—	—	—	—	3.70 Picogram per milliliter Interval 2.0 to 466.7	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interleukin-6: Cycle 1; 72 hours	—	—	—	—	—	—	—	—	—	7.50 Picogram per milliliter Interval 2.0 to 1231.3	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 2 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 4 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 2.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 8 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 24 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 7.5	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 72 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 0 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 2.8	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 2 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 58.5	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 4 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 20.8	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 8 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 3.9	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 0; 24 hours	—	—	—	—	—	—	—	—	—	2.55 Picogram per milliliter Interval 1.7 to 12.7	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 0 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 4.9	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 2 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 5.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 4 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 5.8	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 8 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 3.6	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 24 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 5.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Tumor necrosis factor-alpha: Cycle 1; 72 hours	—	—	—	—	—	—	—	—	—	1.70 Picogram per milliliter Interval 1.7 to 2.9	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 0 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 2 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 4 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 8 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 3.0 to 4.2	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 0; 24 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 47.3	—	—	—	—	—	—	—	—	—	—
Part 2: Concentration of Soluble Cytokines in Serum Interferon-gamma: Cycle 1; 0 hours	—	—	—	—	—	—	—	—	—	4.20 Picogram per milliliter Interval 4.2 to 4.2	—	—	—	—	—	—	—	—	—	—

Adverse Events

Part 1: PF-06863135 0.1 mcg/kg IV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1: PF-06863135 0.3 mcg/kg IV

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part 1: PF-06863135 1 mcg/kg IV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1: PF-06863135 3 mcg/kg IV

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1: PF-06863135 10 mcg/kg IV

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1: PF-06863135 30 mcg/kg IV

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Part 1: PF-06863135 50 mcg/kg IV

Serious events: 5 serious events

Other events: 6 other events

Deaths: 4 deaths

Part 1: PF-06863135 80 mcg/kg SC

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Part 1: PF-06863135 130 mcg/kg SC

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1: PF-06863135 215 mcg/kg SC

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 1: PF-06863135 360 mcg/kg SC

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 1: PF-06863135 600 mcg/kg SC

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1: PF-06863135 1000 mcg/kg SC

Serious events: 5 serious events

Other events: 6 other events

Deaths: 2 deaths

Part 1.1: PF-06863135 Priming Cohort Q1W SC

Serious events: 6 serious events

Other events: 7 other events

Deaths: 3 deaths

Part 1.1: PF-06863135 Priming Cohort Q2W SC

Serious events: 9 serious events

Other events: 13 other events

Deaths: 4 deaths

Part 1C: PF-06863135 + Lenalidomide SC

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1D: PF-06863135 + Pomalidomide SC

Serious events: 8 serious events

Other events: 9 other events

Deaths: 4 deaths

Part 2A: PF-06863135 SC

Serious events: 12 serious events

Other events: 13 other events

Deaths: 10 deaths

Part 1: PF-06863135 Total IV

Serious events: 11 serious events

Other events: 23 other events

Deaths: 19 deaths

Part 1: PF-06863135 Total SC

Serious events: 20 serious events

Other events: 30 other events

Deaths: 17 deaths

Part 1.1: PF-06863135 Total SC

Serious events: 15 serious events

Other events: 20 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: PF-06863135 0.1 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1000 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 2A: PF-06863135 SC n=15 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Cardiac disorders Atrial flutter	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Endocrine disorders Adrenal insufficiency	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Eye disorders Diplopia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Eye disorders Extraocular muscle disorder	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Melaena	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Asthenia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Disease progression	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Fatigue	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Malaise	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Pyrexia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Sudden death	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Immune system disorders Cytokine release syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	55.6% 5/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	46.7% 7/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Adenovirus infection	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Appendicitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Arthritis bacterial	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Bacteraemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Bacterial sepsis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations COVID-19	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations COVID-19 pneumonia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Cellulitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Clostridium difficile colitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Clostridium difficile infection	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Encephalitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Extradural abscess	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Herpes simplex oesophagitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Herpes zoster	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Salmonellosis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Sepsis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Septic shock	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Sinusitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Tracheobronchitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Viral sinusitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Electrocardiogram T wave abnormal	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Depressed level of consciousness	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Hemiparesis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Neurotoxicity	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Sensory disturbance	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Spinal cord compression	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Psychiatric disorders Confusional state	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Surgical and medical procedures Assisted suicide	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Vascular disorders Haematoma	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Vascular disorders Thrombosis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Other adverse events

Other adverse events
Measure	Part 1: PF-06863135 0.1 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 0.3 mcg/kg IV n=3 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 3 mcg/kg IV n=3 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 10 mcg/kg IV n=2 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 30 mcg/kg IV n=5 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 50 mcg/kg IV n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 80 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 130 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 215 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 360 mcg/kg SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 600 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 1000 mcg/kg SC n=6 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q1W SC n=7 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Priming Cohort Q2W SC n=13 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1C: PF-06863135 + Lenalidomide SC n=4 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1D: PF-06863135 + Pomalidomide SC n=9 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 2A: PF-06863135 SC n=15 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total IV n=23 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1: PF-06863135 Total SC n=30 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.	Part 1.1: PF-06863135 Total SC n=20 participants at risk Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	17.4% 4/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 2/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 2/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	80.0% 4/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.7% 6/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	69.2% 9/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 6/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	60.9% 14/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	73.3% 22/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 15/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	44.4% 4/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.4% 7/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 12/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 6/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	39.1% 9/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	86.7% 26/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	35.0% 7/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Neutropenia	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.7% 6/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	84.6% 11/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	77.8% 7/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 10/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.4% 7/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	53.3% 16/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.0% 17/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 2/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	76.9% 10/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 5/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	43.5% 10/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	56.7% 17/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	65.0% 13/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	61.5% 8/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 6/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	21.7% 5/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 9/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 10/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Nausea	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	44.4% 4/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 5/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	36.7% 11/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 5/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	26.7% 8/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	35.0% 7/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Chills	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Fatigue	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	80.0% 4/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	61.5% 8/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	77.8% 7/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	46.7% 7/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.4% 7/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.3% 7/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	55.0% 11/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Injection site reaction	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.7% 6/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	46.2% 6/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 6/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 6/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	53.3% 16/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	60.0% 12/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Oedema peripheral	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 6/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
General disorders Pyrexia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	55.6% 5/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.3% 7/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Immune system disorders Cytokine release syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	80.0% 4/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	83.3% 5/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 6/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.7% 6/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	84.6% 11/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	43.5% 10/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	60.0% 18/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	85.0% 17/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Immune system disorders Hypogammaglobulinaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Pneumonia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Sinusitis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Alanine aminotransferase increased	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 10/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	17.4% 4/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 10/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Blood bilirubin increased	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Blood creatinine increased	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 6/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations SARS-CoV-2 test positive	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Investigations Weight decreased	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 6/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	46.7% 7/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	21.7% 5/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.3% 7/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	35.0% 7/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	55.6% 5/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 6/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	53.8% 7/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.3% 7/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	45.0% 9/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	60.0% 3/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	57.1% 4/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 6/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 6/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 8/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 2/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 2/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 5/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	26.1% 6/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 9/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 5/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	17.4% 4/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 8/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 2/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	17.4% 4/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.1% 3/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 5/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	38.5% 5/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	26.7% 8/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.0% 6/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Dizziness	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Headache	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 4/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	44.4% 4/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 6/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 4/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	28.6% 2/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Paraesthesia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	17.4% 4/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Psychiatric disorders Confusional state	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 3/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	44.4% 4/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 5/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	46.2% 6/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	35.0% 7/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	3.3% 1/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 1/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	66.7% 2/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.0% 3/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 3/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	42.9% 3/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	30.8% 4/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	100.0% 4/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 3/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	40.0% 6/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	23.3% 7/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	35.0% 7/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 2/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.0% 3/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 2/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 4/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	5.0% 1/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	75.0% 3/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	15.4% 2/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	6.7% 1/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	50.0% 1/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	20.0% 1/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	14.3% 1/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	7.7% 1/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	11.1% 1/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	8.7% 2/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 3/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	10.0% 2/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Vascular disorders Hypotension	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/3 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/2 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/5 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	25.0% 1/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	33.3% 2/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 1/6 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/7 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/13 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/4 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	22.2% 2/9 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	13.3% 2/15 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	4.3% 1/23 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	16.7% 5/30 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.	0.00% 0/20 • Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study medication.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER