Trial Outcomes & Findings for A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors (NCT NCT02597036)

Last Updated: 2025-10-23

Results Overview

Recommended Phase 2 dose was determined based on observed safety, pharmacokinetics (PK) and efficacy. However maximum tolerated dose (MTD) was not determined. For the purpose of this study, the MTD is defined as the highest tested dose in a single-agent setting that has less than (\<) 33% probability of causing a DLT. MTD in the combination setting was determined based on the nature and timing of the DLTs in the combination setting. Dose-limiting toxicities were not reported in any treatment cohort. Therefore, the maximum tolerated LY3127804 dose could not be determined.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

Baseline through Cycle 1 (28 Day Cycle)

Results posted on

2025-10-23

Participant Flow

Completers are participants that completes cycle 1 (28 Day Cycle).

Participant milestones

Participant milestones
Measure	Part A Cohort 1: 4 Milligram Per Kilogram (mg/kg) LY3127804 Participants received 4 mg/kg LY3127804 administered as intravenous (IV) infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Overall Study STARTED	3	4	3	3	3	4	6	7	7	7	8	7
Overall Study Received at Least 1 Dose of Study Drug	3	4	3	3	3	4	6	7	7	7	8	7
Overall Study COMPLETED	3	4	3	3	2	3	5	6	7	6	6	5
Overall Study NOT COMPLETED	0	0	0	0	1	1	1	1	0	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Cohort 5: 20 mg/kg LY3127804 Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Overall Study Progressive Disease	1	1	1	0	0	0	0
Overall Study Adverse Event	0	0	0	1	0	0	1
Overall Study Death	0	0	0	0	1	1	0
Overall Study Lost to Follow-up	0	0	0	0	0	1	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1

Baseline Characteristics

A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Cohort 1: 4 mg/kg LY3127804 n=3 Participants Participants received 4 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg n=8 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Total n=62 Participants Total of all reporting groups
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	36 Participants n=36 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	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Age, Continuous	56.30 years STANDARD_DEVIATION 11.72 • n=5 Participants	54.30 years STANDARD_DEVIATION 7.80 • n=7 Participants	58.70 years STANDARD_DEVIATION 13.05 • n=5 Participants	66.00 years STANDARD_DEVIATION 5.57 • n=4 Participants	66.00 years STANDARD_DEVIATION 15.13 • n=21 Participants	62.80 years STANDARD_DEVIATION 10.72 • n=8 Participants	57.80 years STANDARD_DEVIATION 9.41 • n=8 Participants	55.30 years STANDARD_DEVIATION 12.65 • n=24 Participants	51.90 years STANDARD_DEVIATION 19.58 • n=42 Participants	65.60 years STANDARD_DEVIATION 6.53 • n=42 Participants	50.60 years STANDARD_DEVIATION 12.11 • n=42 Participants	54.40 years STANDARD_DEVIATION 9.13 • n=42 Participants	57.30 years STANDARD_DEVIATION 12.08 • n=36 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	26 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=42 Participants	5 Participants n=42 Participants	45 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	16 Participants n=36 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
Race (NIH/OMB) Asian	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
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
Race (NIH/OMB) Black or African American	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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	7 Participants n=24 Participants	4 Participants n=42 Participants	7 Participants n=42 Participants	8 Participants n=42 Participants	7 Participants n=42 Participants	56 Participants n=36 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
Race (NIH/OMB) Unknown or Not Reported	2 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	2 Participants n=36 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	2 participants n=8 Participants	1 participants n=8 Participants	3 participants n=24 Participants	1 participants n=42 Participants	1 participants n=42 Participants	3 participants n=42 Participants	1 participants n=42 Participants	15 participants n=36 Participants
Region of Enrollment France	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants	2 participants n=24 Participants	3 participants n=42 Participants	2 participants n=42 Participants	0 participants n=42 Participants	3 participants n=42 Participants	17 participants n=36 Participants
Region of Enrollment Spain	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	2 participants n=8 Participants	1 participants n=24 Participants	1 participants n=42 Participants	2 participants n=42 Participants	2 participants n=42 Participants	1 participants n=42 Participants	12 participants n=36 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	2 participants n=8 Participants	2 participants n=8 Participants	1 participants n=24 Participants	2 participants n=42 Participants	2 participants n=42 Participants	3 participants n=42 Participants	2 participants n=42 Participants	18 participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline through Cycle 1 (28 Day Cycle)

Population: All randomized participants who received at least one dose of study drug (ramucirumab and/or LY3127804) in Part A, Part B and Part C.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=62 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Recommended Phase 2 Dose of LY3127804 Monotherapy and in Combination With Ramucirumab	20 milligram per kilogram (mg/kg)	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through Cycle 1 (28 Day Cycle)

Population: All randomized participants who received at least one dose of study drug (ramucirumab and/or LY3127804) and had DLTs in Part A, Part B and Part C.

A dose limiting toxicity (DLT) defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of \>14 days; a DLT can be declared if a participant experiences increasing toxicity during treatment.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=8 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Number of Participants With Dose Limiting Toxicities (DLTs)	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: predose, end of infusion (1h), 2h, 24h, 96h, 168h, 336 h following dose on day 1 and at predose, end of infusion (1h), 24h, 168h and 336 h following dose on day 15 and at predose, end of infusion (1h), 2h, 168h, 336h following dose on day 29

Population: All randomized participants who received at least one dose of study drug (LY3127804) with evaluable PK data in Part A, Part B and Part C. Per protocol, similar strength doses of LY3127804 from Part A, B, and C were combined for measuring PK data.

Area under the plasma concentration-time curve of LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (h) was evaluated.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=9 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=9 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=10 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=17 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=12 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804 Day 1 dose	11631 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 30	29817 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 25	33036 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 31	43636 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 25	57917 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 23	81931 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 28	—	—	—	—	—	—
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804 Day 15 dose	16647 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 33	42486 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 22	47084 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 35	65837 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 39	85529 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 22	108015 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 24	—	—	—	—	—	—
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3127804 Day 29 dose	16136 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 27	53889 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 41	62327 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 26	93032 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 25	106655 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 28	120607 microgramhour per milliliter(µghr/mL) Geometric Coefficient of Variation 29	—	—	—	—	—	—

SECONDARY outcome

Timeframe: predose, end of infusion (1h), 24h, 96h, 168h, 336 h following Ramucirumab dose on day 1

Population: All randomized participants who received at least one dose of study drug (ramucirumab and/or LY3127804) with evaluable PK data in Part B and Part C. Per protocol, Part B reporting arms in cohorts 2 to 6 were combined to measure ramucirumab PK in presence of LY3127804.

Area under the serum concentration-time curve of ramucirumab in combination with LY3127804 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) was evaluated following the first dose.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=18 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=7 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Pharmacokinetics: AUC of Ramucirumab in Combination With LY3127804	20615 µg*h/mL Geometric Coefficient of Variation 32	35403 µg*h/mL Geometric Coefficient of Variation 16	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up To 5 Months)

Population: All randomized participants who received at least one dose of study drug (ramucirumab and/or LY3127804) and had a baseline and at least 1 post-baseline ADA assessment in Part A, Part B and Part C.

The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from cycle 1 pre-Dose through 30 days after last dose of study drug that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=3 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Number of Participants With Anti-LY3127804 Antibodies	1 participants	0 participants	0 participants	1 participants	0 participants	0 participants	1 participants	1 participants	0 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Cycle 1 Pre-Dose through 30 Days After Last Dose of Study Drug (Up to 5 Months)

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=3 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Number of Participants With Anti-Ramucirumab Antibodies	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: Baseline through Measured Progressive Disease or Death (Up to 4 Months)

Population: All randomized participants who had adequate baseline and at least 1 post-baseline tumor assessments in Part A, Part B and Part C.

ORR defined as the percentage of participants who achieve a CR or PR as assessed by RECIST v.1.1. The ORR is the number of participants with a complete response (CR) or partial response (PR) divided by the number of randomized participants recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first. Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of longest diameters.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=8 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 60.2	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 60.2	33.3 percentage of participants Interval 4.3 to 77.7	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 41.0	0.0 percentage of participants Interval 0.0 to 41.0	12.5 percentage of participants Interval 0.3 to 52.7	14.3 percentage of participants Interval 0.4 to 57.9

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease or Death (Up to 4 Months)

Population: All randomized participants who had adequate baseline and at least 1 post-baseline tumor assessments in Part A, Part B and Part C.

Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy.

Outcome measures

Outcome measures
Measure	All Part A , Part B and Part C Participants n=3 Participants Part A: Participants received escalating doses of 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg and 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle. Part B: Participants received escalating doses of 8 mg/kg / 12 mg/kg / 16 mg/kg / 20 mg/kg / 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle. Part C: Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 Participants Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 Participants Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 Participants Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 Participants Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 Participants Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 Participants Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=8 Participants Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 Participants Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Progression Free Survival (PFS)	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.	NA Months Median and 95% CI could not be calculated due to insufficient number of participants with events.

Adverse Events

Part A Cohort 1: 4 mg/kg LY3127804

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A Cohort 2: 8 mg/kg LY3127804

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A Cohort 3: 12 mg/kg LY3127804

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A Cohort 4: 16 mg/kg LY3127804

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A Cohort 5: 20 mg/kg LY3127804

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A Cohort 6: 27 mg/kg LY3127804

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab

Serious events: 2 serious events

Other events: 8 other events

Deaths: 3 deaths

Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A Cohort 1: 4 mg/kg LY3127804 n=3 participants at risk Participants received 4 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 participants at risk Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 participants at risk Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 participants at risk Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 participants at risk Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 participants at risk Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 participants at risk Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=8 participants at risk Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 participants at risk Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Cardiac disorders Acute coronary syndrome	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Pyrexia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Device related infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Mucosal infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Psoas abscess	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Transaminases increased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Pharyngeal hemorrhage	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Hypertension	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.

Other adverse events

Other adverse events
Measure	Part A Cohort 1: 4 mg/kg LY3127804 n=3 participants at risk Participants received 4 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 2: 8 mg/kg LY3127804 n=4 participants at risk Participants received 8 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 3: 12 mg/kg LY3127804 n=3 participants at risk Participants received 12 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 4: 16 mg/kg LY3127804 n=3 participants at risk Participants received 16 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 5: 20 mg/kg LY3127804 n=3 participants at risk Participants received 20 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part A Cohort 6: 27 mg/kg LY3127804 n=4 participants at risk Participants received 27 mg/kg LY3127804 administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 2: 8 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=6 participants at risk Participants received 8 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 3: 12 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 12 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 4: 16 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 16 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 5: 20 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=7 participants at risk Participants received 20 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part B Cohort 6: 27 mg/kg LY3127804 + 8 mg/kg Ramucirumab n=8 participants at risk Participants received 27 mg/kg LY3127804 plus 8 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.	Part C: 20 mg/kg LY3127804 +12 mg/kg Ramucirumab n=7 participants at risk Participants received 20 mg/kg LY3127804 plus 12 mg/kg ramucirumab administered as IV infusion on days 1 and 15 of a 28-day cycle.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 2/8 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	75.0% 6/8 • Number of events 7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Blood and lymphatic system disorders Hypocoagulable state	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Cardiac disorders Atrial flutter	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Eye disorders Vision blurred	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	37.5% 3/8 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 2/4 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 2/8 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	37.5% 3/8 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Colitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Constipation	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	66.7% 2/3 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	57.1% 4/7 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Duodenitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Food poisoning	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Asthenia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Chest discomfort	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Chest pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Chills	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Fatigue	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	75.0% 3/4 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 3/6 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 4/8 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Gait disturbance	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Generalised oedema	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Inflammation	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Influenza like illness	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Malaise	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 2/4 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 2/6 • Number of events 6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	42.9% 3/7 • Number of events 5 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	57.1% 4/7 • Number of events 6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 4/8 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Puncture site pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Pyrexia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
General disorders Xerosis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Hepatobiliary disorders Deficiency of bile secretion	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Hepatobiliary disorders Jaundice	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Cellulitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Folliculitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Influenza	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Oral candidiasis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Oral herpes	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Oral infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Pharyngitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Rhinitis	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Sepsis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Sinusitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Skin infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Infections and infestations Wound infection	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Injury, poisoning and procedural complications Wound	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Blood creatinine increased	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Weight decreased	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Investigations Weight increased	33.3% 1/3 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 2/6 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Neck mass	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 2/6 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Amnesia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Balance disorder	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Cognitive disorder	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Dysarthria	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Dysgeusia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Headache	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 2/4 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 3/6 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	42.9% 3/7 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Hemianopia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Lethargy	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Neuralgia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Paraesthesia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 2/8 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Presyncope	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Syncope	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Tremor	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Nervous system disorders Vocal cord paralysis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Agitation	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Depression	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Renal and urinary disorders Chromaturia	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 2/6 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	16.7% 1/6 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Embolism	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Hot flush	33.3% 1/3 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Hypertension	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	50.0% 3/6 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	28.6% 2/7 • Number of events 2 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	57.1% 4/7 • Number of events 13 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	37.5% 3/8 • Number of events 6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	57.1% 4/7 • Number of events 9 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Hypotension	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Lymphoedema	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	12.5% 1/8 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Raynaud's phenomenon	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	25.0% 1/4 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Systolic hypertension	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.
Vascular disorders Thrombosis	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/3 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/4 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/6 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/7 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	0.00% 0/8 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.	14.3% 1/7 • Number of events 1 • Baseline Up to 54 Months All randomized participants in Part A, Part B and Part C.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60