Trial Outcomes & Findings for A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma (NCT NCT02659020)

Last Updated: 2022-05-09

Results Overview

A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Febrile neutropenia with documented Grade ≥3 infection or sepsis 2. Grade 4 neutropenia lasting 7 days or longer. 3. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage. 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

310 participants

Primary outcome timeframe

Cycle 1 (Up To 21 Days)

Results posted on

2022-05-09

Participant Flow

Completers included participants who died from any cause.

Participant milestones

Participant milestones
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Overall Study STARTED	21	18	15	81	46	86	43
Overall Study Received at Least 1 Dose of Study Drug	21	18	15	81	45	86	43
Overall Study COMPLETED	18	15	14	65	40	75	35
Overall Study NOT COMPLETED	3	3	1	16	6	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Overall Study Adverse Event	0	0	0	2	0	0	2
Overall Study Lost to Follow-up	1	2	1	6	1	5	0
Overall Study Physician Decision	0	0	0	1	1	0	1
Overall Study Withdrawal by Subject	2	1	0	3	3	6	3
Overall Study Progressive Disease	0	0	0	4	1	0	2

Baseline Characteristics

A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=21 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=15 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) n=81 Participants This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=46 Participants This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) n=86 Participants This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=43 Participants This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Total n=310 Participants Total of all reporting groups
Age, Customized <65 years	20 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	66 Participants n=4 Participants	27 Participants n=21 Participants	66 Participants n=8 Participants	30 Participants n=8 Participants	227 Participants n=24 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	15 Participants n=4 Participants	19 Participants n=21 Participants	20 Participants n=8 Participants	13 Participants n=8 Participants	83 Participants n=24 Participants
Age, Customized <=18 years	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
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	48 Participants n=4 Participants	28 Participants n=21 Participants	58 Participants n=8 Participants	28 Participants n=8 Participants	188 Participants n=24 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	33 Participants n=4 Participants	18 Participants n=21 Participants	28 Participants n=8 Participants	15 Participants n=8 Participants	122 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	28 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	71 Participants n=4 Participants	39 Participants n=21 Participants	73 Participants n=8 Participants	36 Participants n=8 Participants	264 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	3 Participants n=8 Participants	18 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	11 Participants n=24 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	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	14 Participants n=24 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	61 Participants n=4 Participants	30 Participants n=21 Participants	70 Participants n=8 Participants	34 Participants n=8 Participants	233 Participants n=24 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants	3 Participants n=8 Participants	42 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	8 Participants n=24 Participants
Region of Enrollment Hungary	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	0 Participants n=8 Participants	11 Participants n=24 Participants
Region of Enrollment United States	10 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	29 Participants n=4 Participants	36 Participants n=21 Participants	28 Participants n=8 Participants	30 Participants n=8 Participants	161 Participants n=24 Participants
Region of Enrollment Poland	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	8 Participants n=24 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants	3 Participants n=21 Participants	12 Participants n=8 Participants	5 Participants n=8 Participants	31 Participants n=24 Participants
Region of Enrollment Italy	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	0 Participants n=8 Participants	6 Participants n=24 Participants
Region of Enrollment Israel	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	4 Participants n=8 Participants	18 Participants n=24 Participants
Region of Enrollment France	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	9 Participants n=24 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	11 Participants n=8 Participants	2 Participants n=8 Participants	24 Participants n=24 Participants
Region of Enrollment Spain	11 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=8 Participants	2 Participants n=8 Participants	37 Participants n=24 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up To 21 Days)

Population: Phase 1b: All participants who received at least one dose of Olaratumab.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=21 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=15 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)	1 Participants	4 Participants	3 Participants	—

PRIMARY outcome

Timeframe: Baseline to Date of Death Due to Any Cause (Up To 38 Months)

OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=81 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=86 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Overall Survival (OS) (Olaratumab-Naive)	16.76 Months Interval 15.28 to 25.4	18.04 Months Interval 13.17 to 22.9	—	—

SECONDARY outcome

Timeframe: Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8

Population: Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.

Cmax of Olaratumab.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=20 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=33 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab Cycle 1 (Day 1)	432 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 24	572 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 25	—	—
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab Cycle 1 (Day 8)	460 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 25	697 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 20	—	—
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab Cycle 3 (Day 1)	523 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 38	644 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 20	—	—
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab Cycle 3 (Day 8)	513 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 21	689 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 20	—	—

SECONDARY outcome

Timeframe: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1

Population: Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.

Cmin of Olaratumab.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=20 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=31 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab Cycle 1 (Day 1)	95.9 μg/mL Geometric Coefficient of Variation 37	142 μg/mL Geometric Coefficient of Variation 38	—	—
Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab Cycle 1 (Day 8)	64.3 μg/mL Geometric Coefficient of Variation 64	93.3 μg/mL Geometric Coefficient of Variation 47	—	—
Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab Cycle 3 (Day 1)	137 μg/mL Geometric Coefficient of Variation 40	252 μg/mL Geometric Coefficient of Variation 36	—	—

SECONDARY outcome

Timeframe: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8

Population: Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.

T1/2 of Olaratumab.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=19 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=33 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab Cycle 1 (Day 1)	4.60 days Geometric Coefficient of Variation 34	4.29 days Geometric Coefficient of Variation 28	—	—
Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab Cycle 1 (Day 8)	6.25 days Geometric Coefficient of Variation 25	6.62 days Geometric Coefficient of Variation 27	—	—
Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab Cycle 3 (Day 1)	5.17 days Geometric Coefficient of Variation 36	6.36 days Geometric Coefficient of Variation 41	—	—
Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab Cycle 3 (Day 8)	5.82 days Geometric Coefficient of Variation 30	6.39 days Geometric Coefficient of Variation 32	—	—

SECONDARY outcome

Timeframe: Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)

Population: Phase 1b/2: All participants who received at least one dose of Gemcitabine and had evaluable PK data.

Cmax of Gemcitabine.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=24 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=87 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=88 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b/2: PK: Cmax of Gemcitabine	2.79 μg/mL Geometric Coefficient of Variation 70	3.49 μg/mL Geometric Coefficient of Variation 50	3.01 μg/mL Geometric Coefficient of Variation 122	2.35 μg/mL Geometric Coefficient of Variation 105

SECONDARY outcome

Timeframe: Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)

Population: Phase 1b/2: Zero participants analysed. Due to short half-life of Gemcitabine, there was insufficient quantifiable data in the elimination phase to calculate AUC\[0-∞\] for any of the participants.

AUC\[0-∞\] of Gemcitabine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8

Population: Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data.

Cmax of Docetaxel.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=30 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=71 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=73 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b/2: PK: Cmax of Docetaxel	903 Nanograms per milliliter Geometric Coefficient of Variation 143	1110 Nanograms per milliliter Geometric Coefficient of Variation 84	1030 Nanograms per milliliter Geometric Coefficient of Variation 134	827 Nanograms per milliliter Geometric Coefficient of Variation 102

SECONDARY outcome

Timeframe: 5 min, 1, 3, 24, 48 h post-dose on Cycle 1 Day 8

Population: Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data. For phase 2, zero participants analysed due to data not collected for AUC \[0-∞\] of Docetaxel.

AUC \[0-∞\] of Docetaxel.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=7 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel	4440 nanograms*hours per milliliter Geometric Coefficient of Variation 103	2990 nanograms*hours per milliliter Geometric Coefficient of Variation 83	—	—

SECONDARY outcome

Timeframe: Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8

Population: Phase 1b/2: All participants who received at least one dose of Olaratumab and had evaluable PK data. Phase 1b and phase 2 participants olaratumab PK data was planned to be pooled for the population PK analysis and compared to a validated PK model to confirm that PK parameters were similar to analyses from previous olaratumab studies.

Population PK: Clearance of Olaratumab

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=178 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b/2: Population PK: Clearance of Olaratumab	0.0186 Liter Per Hour Interval 0.0175 to 0.0192	—	—	—

SECONDARY outcome

Timeframe: Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8

The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=178 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b/2: Population PK: Volume of Distribution at Steady State (Vss) of Olaratumab	5.14 Liter Interval 4.68 to 5.54	—	—	—

SECONDARY outcome

Timeframe: Baseline to Date of Death Due to Any Cause (Up To 38 Months)

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=46 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=43 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Overall Survival (Olaratumab Pre-Treated)	19.84 Months Interval 14.19 to There were not enough events to estimate the upper confidence limit.	17.31 Months Interval 10.81 to 20.3	—	—

SECONDARY outcome

Timeframe: Baseline to Objective Disease Progression or Death from Any Cause (Up To 38 Months)

Population: Phase 2: All randomized participants (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)=20" "Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)=21," "Olaratumab + Gemcitabine + Docetaxel (Olaratumab pre-treated)=12," "Placebo + Gemcitabine + Docetaxel (Olaratumab pre-treated)=16."

PFS was defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 \[RECIST v.1.1\]) or death due to any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=81 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=86 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=46 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=43 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Progression Free Survival (PFS)	7.62 Months Interval 5.13 to 8.54	4.37 Months Interval 2.86 to 6.87	5.45 Months Interval 2.76 to 8.71	4.17 Months Interval 2.2 to 6.9

SECONDARY outcome

Timeframe: Baseline to Objective Disease Progression or Start of New Anti-Cancer Therapy (Up To 38 Months)

Population: Phase 2: All randomized participants.

ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=81 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=86 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=46 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=43 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])	32.1 Percentage of participants Interval 22.2 to 43.4	23.3 Percentage of participants Interval 14.8 to 33.6	30.4 Percentage of participants Interval 17.7 to 45.8	14 Percentage of participants Interval 5.3 to 27.9

SECONDARY outcome

Timeframe: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up To 38 Months)

Population: Phase 2: All randomized participants.

DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=81 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=86 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=46 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=43 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)	74.1 Percentage of participants Interval 63.1 to 83.2	72.1 Percentage of participants Interval 61.4 to 81.2	67.4 Percentage of participants Interval 52.0 to 80.5	62.8 Percentage of participants Interval 46.7 to 77.0

SECONDARY outcome

Timeframe: Baseline to Follow-up (Up To 24 Months)

Population: Phase 2: All randomized participants who had baseline and at least one post-baseline assessment (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) = 30," "Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)=23," "Olaratumab + Gemcitabine + Docetaxel (Olaratumab pre-treated)=17," "Placebo + Gemcitabine + Docetaxel (Olaratumab pre-treated)=8."

The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the patient has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=68 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=71 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=41 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=34 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"	3.61 Months Interval 2.66 to 8.57	2.27 Months Interval 1.41 to 6.54	3.15 Months Interval 1.41 to 7.62	2.20 Months Interval 0.76 to 3.02

SECONDARY outcome

Timeframe: Baseline to Follow-up (Up to 33 months)

Population: Phase 2: All randomized participants who had baseline and at least one post-baseline assessment.

The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=75 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=80 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=45 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=41 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Constipation	3.25 Months Interval 2.14 to 5.98	2.86 Months Interval 1.48 to There were not enough events to estimate the upper confidence limit.	4.63 Months Interval 1.91 to 12.91	3.81 Months Interval 1.97 to There were not enough events to estimate the upper confidence limit.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Fatigue	0.95 Months Interval 0.76 to 1.12	0.95 Months Interval 0.76 to 1.45	0.85 Months Interval 0.72 to 1.41	0.76 Months Interval 0.72 to 1.84
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Nausea and vomiting	3.78 Months Interval 2.14 to There were not enough events to estimate the upper confidence limit.	2.46 Months Interval 0.99 to 13.34	3.98 Months Interval 1.41 to There were not enough events to estimate the upper confidence limit.	13.17 Months Interval 1.64 to There were not enough events to estimate the upper confidence limit.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Pain	4.67 Months Interval 2.33 to 9.53	0.99 Months Interval 0.79 to 2.76	2.43 Months Interval 1.41 to 8.77	3.06 Months Interval 0.76 to 5.55
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Dyspnoea	2.14 Months Interval 1.51 to 3.06	2.14 Months Interval 1.48 to 2.86	2.33 Months Interval 1.45 to 14.09	2.79 Months Interval 1.45 to 8.05
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Insomnia	5.32 Months Interval 2.33 to 7.72	4.24 Months Interval 1.48 to 16.82	1.91 Months Interval 1.41 to 6.47	5.09 Months Interval 1.45 to There were not enough events to estimate the upper confidence limit.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Appetite loss	1.12 Months Interval 0.82 to 2.14	2.56 Months Interval 1.64 to 3.98	1.41 Months Interval 0.85 to 3.52	1.97 Months Interval 1.38 to 4.04
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Diarrhoea	1.41 Months Interval 0.99 to 3.68	1.81 Months Interval 1.41 to 4.24	3.55 Months Interval 1.41 to 6.05	3.52 Months Interval 1.97 to There were not enough events to estimate the upper confidence limit.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales. Financial difficulties	NA Months Interval 5.32 to There were not enough events to estimate the median, upper confidence limit.	7.66 Months Interval 3.29 to There were not enough events to estimate the upper confidence limit.	7.29 Months Interval 2.33 to 7.85	NA Months Interval 3.94 to There were not enough events to estimate the upper confidence limit.

SECONDARY outcome

Timeframe: Cycle 1 (Day 1), Follow-up (Up to 38 Months)

Population: Phase 2: All randomized participants who completed EQ-5D-5L.

The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=71 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=75 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=42 Participants Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel n=35 Participants Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) EQ-5D-5L - VAS Score [Cycle 1 (Day 1)]	73.5 score on a scale Standard Deviation 18.9	72.7 score on a scale Standard Deviation 18.1	76.2 score on a scale Standard Deviation 19.6	70.3 score on a scale Standard Deviation 23.8
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) EQ-5D-5L - Index Value [Cycle 1 (Day 1)]	0.80 score on a scale Standard Deviation 0.17	0.81 score on a scale Standard Deviation 0.17	0.83 score on a scale Standard Deviation 0.15	0.83 score on a scale Standard Deviation 0.22
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) EQ-5D-5L - Index Value [Follow-up (Up to 38 Months)]	0.74 score on a scale Standard Deviation 0.21	0.71 score on a scale Standard Deviation 0.26	0.80 score on a scale Standard Deviation 0.20	0.76 score on a scale Standard Deviation 0.24
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) EQ-5D-5L - VAS Score [Follow-up (Up to 38 Months)]	68.7 score on a scale Standard Deviation 16.5	63.0 score on a scale Standard Deviation 21.6	74.8 score on a scale Standard Deviation 21.8	70.8 score on a scale Standard Deviation 24.2

SECONDARY outcome

Timeframe: Baseline through Follow-Up (Up to 38 Months)

Population: Phase 2: All randomized participants who received at least one dose of Olaratumab and had evaluable immunogenicity data.

Number of Participants with Treatment Emergent Anti-Olaratumab Antibodies

Outcome measures

Outcome measures
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=77 Participants Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=43 Participants Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies	0 Participants	0 Participants	—	—

Adverse Events

Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel

Serious events: 6 serious events

Other events: 21 other events

Deaths: 15 deaths

Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel

Serious events: 9 serious events

Other events: 18 other events

Deaths: 11 deaths

Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel

Serious events: 9 serious events

Other events: 15 other events

Deaths: 12 deaths

Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)

Serious events: 44 serious events

Other events: 78 other events

Deaths: 54 deaths

Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated)

Serious events: 21 serious events

Other events: 45 other events

Deaths: 28 deaths

Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)

Serious events: 38 serious events

Other events: 81 other events

Deaths: 58 deaths

Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated)

Serious events: 23 serious events

Other events: 42 other events

Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=21 participants at risk Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=15 participants at risk Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) n=81 participants at risk This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=45 participants at risk This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) n=86 participants at risk This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=43 participants at risk This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Bandaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial tachycardia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac failure	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Supraventricular tachycardia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Enterocolitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Mucosal inflammation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Peripheral swelling	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.1% 7/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 6/43 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Sudden death	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic failure	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic shock	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anorectal infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Arthritis infective	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacteraemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Campylobacter infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	4.8% 1/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Device related infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Erysipelas	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gastrointestinal infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Neutropenic sepsis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	9.5% 2/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia bacterial	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia viral	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rectal abscess	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Septic shock	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Arterial bypass occlusion	4.8% 1/21 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations International normalised ratio increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Neutrophil count decreased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Troponin increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Epilepsy	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Facial paralysis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Nervous system disorder	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Polyneuropathy	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Seizure	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Spinal cord compression	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal failure	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Capillary leak syndrome	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Haematoma	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Peripheral artery stenosis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Phase 1b: Cohort 1 - 15 mg/kg Olaratumab + Gemcitabine + Docetaxel n=21 participants at risk Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=18 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 1b: Cohort 2 Expansion - 20 mg/kg Olaratumab + Gemcitabine + Docetaxel n=15 participants at risk Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m\^2) on days 1, 8 plus docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) n=81 participants at risk This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=45 participants at risk This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) n=86 participants at risk This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.	Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-treated) n=43 participants at risk This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m\^2 on days 1, 8 and docetaxel 75 mg/m\^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Metabolism and nutrition disorders Hypoalbuminaemia	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.9% 8/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Adrenal insufficiency	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypothyroidism	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	61.9% 13/21 • Number of events 42 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	66.7% 12/18 • Number of events 54 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	60.0% 9/15 • Number of events 24 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	53.1% 43/81 • Number of events 168 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	73.3% 33/45 • Number of events 145 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	54.7% 47/86 • Number of events 147 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	46.5% 20/43 • Number of events 57 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	14.3% 3/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	24.7% 20/81 • Number of events 55 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.9% 24/86 • Number of events 43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	9.5% 2/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 12 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 9/45 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.1% 13/86 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 6/43 • Number of events 12 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Tachycardia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Ear pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Dry eye	4.8% 1/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Lacrimation increased	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Photopsia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Vision blurred	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	9.5% 2/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 9/81 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 12 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 10/86 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 6/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	28.6% 6/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.9% 21/81 • Number of events 29 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 12/45 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.3% 20/86 • Number of events 24 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.9% 12/43 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	33.3% 7/21 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	44.4% 8/18 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	44.4% 36/81 • Number of events 84 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	46.7% 21/45 • Number of events 42 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.9% 30/86 • Number of events 50 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.6% 14/43 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 8/86 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal fistula	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	23.8% 5/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	50.0% 9/18 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	46.9% 38/81 • Number of events 59 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	44.4% 20/45 • Number of events 31 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	46.5% 40/86 • Number of events 73 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.9% 12/43 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oral pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Proctalgia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	19.0% 4/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.0% 17/81 • Number of events 34 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.4% 15/86 • Number of events 26 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.6% 11/43 • Number of events 20 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Toothache	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	14.3% 3/21 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.9% 25/81 • Number of events 30 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.1% 13/86 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 7/43 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	19.0% 4/21 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 12/81 • Number of events 59 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 14/86 • Number of events 58 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Catheter site pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.9% 8/81 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 7/43 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Device related thrombosis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Face oedema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	61.9% 13/21 • Number of events 32 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	77.8% 14/18 • Number of events 35 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	80.0% 12/15 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	60.5% 49/81 • Number of events 126 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	75.6% 34/45 • Number of events 76 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	52.3% 45/86 • Number of events 110 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	53.5% 23/43 • Number of events 44 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Infusion site extravasation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Localised oedema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Malaise	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 8/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-pitting oedema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	38.1% 8/21 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	45.7% 37/81 • Number of events 67 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	46.7% 21/45 • Number of events 36 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 23/86 • Number of events 33 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.6% 14/43 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Peripheral swelling	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 8/86 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	28.6% 6/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	44.4% 8/18 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.4% 23/81 • Number of events 51 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 10/45 • Number of events 12 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.2% 26/86 • Number of events 49 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.6% 11/43 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Folliculitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Paronychia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Rash pustular	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 3/15 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 14/86 • Number of events 19 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 15/81 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 8/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vaginal infection	0.00% 0/11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.3% 1/7 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/48 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/58 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wound complication	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	23.8% 5/21 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 6/18 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.0% 13/81 • Number of events 36 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.8% 8/45 • Number of events 19 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.6% 16/86 • Number of events 33 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 7/43 • Number of events 20 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	19.0% 4/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.8% 11/86 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	19.0% 4/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	19.0% 4/21 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Haemoglobin decreased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations International normalised ratio increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Lymphocyte count decreased	4.8% 1/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.9% 8/81 • Number of events 31 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 32 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.5% 9/86 • Number of events 33 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Neutrophil count decreased	4.8% 1/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.8% 16/81 • Number of events 44 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	44.4% 20/45 • Number of events 72 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 14/86 • Number of events 32 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.9% 7/18 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 19/81 • Number of events 50 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 15/45 • Number of events 44 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.6% 16/86 • Number of events 46 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 7/43 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Transaminases increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight increased	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count decreased	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 12/81 • Number of events 50 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 12/45 • Number of events 63 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 12/86 • Number of events 43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	23.8% 5/21 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 6/18 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.9% 21/81 • Number of events 33 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 11/45 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.4% 15/86 • Number of events 30 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.6% 14/43 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	19.0% 4/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 10/45 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 4/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 9/45 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 10/86 • Number of events 24 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 7/43 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	4.8% 1/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	9.5% 2/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.0% 13/81 • Number of events 24 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.3% 14/86 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	19.0% 4/21 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 6/15 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.1% 7/86 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 9/81 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.1% 7/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 6/43 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 7/21 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 6/18 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.7% 4/15 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.8% 16/81 • Number of events 27 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.9% 13/45 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.8% 11/86 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.6% 11/43 • Number of events 19 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.0% 13/81 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 8/86 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	9.5% 2/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 11/81 • Number of events 26 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.5% 9/86 • Number of events 12 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dysgeusia	14.3% 3/21 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.9% 7/18 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.8% 12/81 • Number of events 20 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.9% 13/45 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.8% 11/86 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.6% 14/43 • Number of events 18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	23.8% 5/21 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 15/81 • Number of events 23 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.1% 13/86 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Memory impairment	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Paraesthesia	4.8% 1/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.2% 10/45 • Number of events 20 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.1% 13/86 • Number of events 31 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.9% 9/43 • Number of events 14 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Sciatica	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Taste disorder	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Depression	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 15/81 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.1% 7/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.3% 10/43 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Nightmare	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Chromaturia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Micturition urgency	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Proteinuria	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 6/18 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.8% 16/81 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.9% 13/45 • Number of events 21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	24.4% 21/86 • Number of events 27 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.9% 9/43 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 3/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.9% 7/18 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 5/15 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	23.5% 19/81 • Number of events 30 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 15/45 • Number of events 30 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.9% 18/86 • Number of events 25 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.9% 12/43 • Number of events 19 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	19.0% 4/21 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.8% 16/81 • Number of events 19 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.8% 17/86 • Number of events 22 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.9% 9/43 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 3/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 9/81 • Number of events 11 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.3% 4/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.6% 7/81 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Productive cough	4.8% 1/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	38.1% 8/21 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.8% 5/18 • Number of events 10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	35.8% 29/81 • Number of events 35 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	37.2% 32/86 • Number of events 44 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis acneiform	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 4/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 5/45 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/43 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Nail dystrophy	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 2/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.6% 7/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.5% 3/86 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.4% 6/81 • Number of events 16 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.9% 8/81 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	18.5% 15/81 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.8% 11/86 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.7% 3/81 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 3/45 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Surgical and medical procedures Orchidectomy	0.00% 0/10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/33 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/17 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/28 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 6/86 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Embolism venous	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Flushing	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 2/18 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	12.3% 10/81 • Number of events 13 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.4% 2/45 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 4/86 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.6% 5/43 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hot flush	4.8% 1/21 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.2% 1/45 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 9 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.0% 3/43 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	14.3% 3/21 • Number of events 3 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 5/81 • Number of events 20 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 6/45 • Number of events 6 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.1% 7/86 • Number of events 23 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.0% 6/43 • Number of events 7 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypotension	9.5% 2/21 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/18 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.3% 2/15 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.9% 4/81 • Number of events 4 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.8% 8/45 • Number of events 8 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 5/86 • Number of events 5 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.7% 2/43 • Number of events 2 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Peripheral venous disease	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/81 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/86 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Phlebitis	0.00% 0/21 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 1/18 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/15 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/45 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.2% 1/86 • Number of events 1 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/43 • Baseline to Follow-up (Up To 38 Months) Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

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