Trial Outcomes & Findings for A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer (NCT NCT03086369)

Last Updated: 2022-06-28

Results Overview

A DLT is defined as an adverse event 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 4.03: 1. Any febrile neutropenia 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage 3. Grade 4 neutropenia lasting 7 days or longer 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc. 5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

184 participants

Primary outcome timeframe

Cycle 1 (Up to 28 days)

Results posted on

2022-06-28

Participant Flow

Completers included participants who died from any cause.

Participant milestones

Participant milestones
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\^2) and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Overall Study STARTED	3	7	12	82	80
Overall Study Received at Least 1 Dose of Study Drug	3	7	12	81	78
Overall Study COMPLETED	2	7	12	73	73
Overall Study NOT COMPLETED	1	0	0	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\^2) and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Overall Study Lost to Follow-up	1	2	1
Overall Study Physician Decision	0	1	2
Overall Study Withdrawal by Subject	0	5	3
Overall Study Progressive Disease	0	1	1

Baseline Characteristics

A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=7 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=12 Participants Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=82 Participants Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine n=80 Participants Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Total n=184 Participants Total of all reporting groups
Age, Categorical <=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
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	32 Participants n=4 Participants	37 Participants n=21 Participants	76 Participants n=8 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	50 Participants n=4 Participants	43 Participants n=21 Participants	108 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	29 Participants n=4 Participants	35 Participants n=21 Participants	72 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	53 Participants n=4 Participants	45 Participants n=21 Participants	112 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	74 Participants n=4 Participants	70 Participants n=21 Participants	165 Participants n=8 Participants
Ethnicity (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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	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
Race (NIH/OMB) White	3 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	72 Participants n=4 Participants	73 Participants n=21 Participants	167 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants
Region of Enrollment United States	1 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	76 Participants n=4 Participants	73 Participants n=21 Participants	162 Participants n=8 Participants
Region of Enrollment Germany	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	13 Participants n=8 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to 28 days)

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

Outcome measures

Outcome measures
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=7 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=12 Participants Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Baseline to Date of Death from Any Cause (Up To 29 Months)

Population: All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=26, Placebo+Nab-paclitaxel+Gemcitabine=21.

OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.

Outcome measures

Outcome measures
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=82 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=80 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 2: Overall Survival (OS)	9.10 Months Interval 7.49 to 14.09	10.81 Months Interval 8.51 to 14.75	—	—	—

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 15, Cycle 3 Day 1, Cycle 3 Day 15

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

PK: Cmin of olaratumab

Outcome measures

Outcome measures
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=5 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=9 Participants Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=66 Participants Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab Cycle 3 (Day 1)	204 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 13	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 184 μg/mL	173 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 33	147 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 38	—
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab Cycle 1 (Day 1)	128 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 36	86.3 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 90	87.8 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 91	112 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 40	—
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab Cycle 1 (Day 15)	78.7 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 42	172 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 76	101 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 36	94.7 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 62	—
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab Cycle 3 (Day 15)	159 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 17	NA micrograms per milliliter (μg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 99.7 μg/mL	101 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 37	106 micrograms per milliliter (μg/mL) Geometric Coefficient of Variation 68	—

SECONDARY outcome

Timeframe: Baseline through Follow-up (Up To 29 Months)

Population: All randomized participants in phase 2 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=81 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to Date of Death from Any Cause (Approximately 9 Months)

Population: Phase 1b: Zero participants analysed as data was not collected. OS was not measured in phase 1b.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Disease Progression or Death (Up To 26 Months)

Population: All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=24, Placebo+Nab-paclitaxel+Gemcitabine=26.

PFS is 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 in the absence of progressive disease (PD). 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. Participants who did not progress or are lost to follow-up 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. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.

Outcome measures

Outcome measures
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=82 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=80 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 2: Progression-Free Survival (PFS)	5.55 Months Interval 4.14 to 7.0	6.41 Months Interval 5.42 to 7.98	—	—	—

SECONDARY outcome

Timeframe: Baseline through Disease Progression or Death (Up To 26 Months)

Population: All participants in phase 1b/2.

ORR is the best overall tumor response of CR or 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=7 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=12 Participants Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=82 Participants Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine n=80 Participants Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)	33.3 Percentage of participants	14.3 Percentage of participants	0 Percentage of participants	30.5 Percentage of participants	33.8 Percentage of participants

SECONDARY outcome

Timeframe: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)

Population: All participants in phase 1b/2 who had CR or PR responses. For phase 1b cohort expansion arm, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.

DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.

Outcome measures

Outcome measures
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=1 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=1 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=25 Participants Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine n=27 Participants Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 1b/2: Duration of Response (DoR)	NA Months Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 6.24 months.	NA Months Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 3.68 months.	—	5.55 Months Interval 2.63 to 9.23	5.55 Months Interval 3.84 to 7.26

SECONDARY outcome

Timeframe: Baseline through Follow-up (Up To 21 Months)

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

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 participant 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=51 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=47 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"	14.13 Months Interval 5.19 to There were not enough events to estimate the upper confidence limit.	6.11 Months Interval 2.04 to 9.95	—	—	—

SECONDARY outcome

Timeframe: Baseline through Follow-up (Up To 21 Months)

Population: All randomized participants in phase 2 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=68 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=66 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
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	NA Months Interval 2.79 to There were not enough events to estimate median, upper confidence limit.	2.86 Months Interval 1.94 to There were not enough events to estimate 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. Constipation	NA Months Interval 2.76 to There were not enough events to estimate median, upper confidence limit.	NA Months Interval 1.94 to There were not enough events to estimate median, 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. Diarrhoea	2.79 Months Interval 1.87 to There were not enough events to estimate upper confidence limit.	1.97 Months Interval 1.91 to There were not enough events to estimate 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. Dyspnoea	2.79 Months Interval 2.1 to There were not enough events to estimate upper confidence limit.	3.12 Months Interval 2.07 to There were not enough events to estimate 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	1.87 Months Interval 1.05 to 2.33	1.87 Months Interval 1.12 to 2.07	—	—	—
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 2.37 to There were not enough events to estimate median, upper confidence limit.	NA Months Interval 2.79 to There were not enough events to estimate median, 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. Insomnia	3.19 Months Interval 2.1 to There were not enough events to estimate upper confidence limit.	NA Months Interval 2.83 to There were not enough events to estimate median, 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. Nausea and vomiting	3.19 Months Interval 2.1 to There were not enough events to estimate upper confidence limit.	2.86 Months Interval 1.97 to There were not enough events to estimate 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	NA Months Interval 2.76 to There were not enough events to estimate median, upper confidence limit.	3.25 Months Interval 2.04 to There were not enough events to estimate upper confidence limit.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 7 Day 1

Population: All randomized participants in phase 2 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=70 Participants Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=70 Participants Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) Index Value [Cycle 1 (Day1)]	0.8 score on a scale Standard Deviation 0.2	0.8 score on a scale Standard Deviation 0.2	—	—	—
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) Index Value [Cycle 7 (Day1)]	0.8 score on a scale Standard Deviation 0.1	0.8 score on a scale Standard Deviation 0.2	—	—	—
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) VAS Score [Cycle 1 (Day1)]	70.1 score on a scale Standard Deviation 21.7	69.7 score on a scale Standard Deviation 20.4	—	—	—
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) VAS Score [Cycle 7 (Day1)]	71.7 score on a scale Standard Deviation 20.2	73.2 score on a scale Standard Deviation 22.5	—	—	—

Adverse Events

Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine

Serious events: 3 serious events

Other events: 7 other events

Deaths: 7 deaths

Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine

Serious events: 8 serious events

Other events: 12 other events

Deaths: 12 deaths

Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine

Serious events: 50 serious events

Other events: 79 other events

Deaths: 60 deaths

Phase 2: Placebo + Nab-paclitaxel + Gemcitabine

Serious events: 41 serious events

Other events: 78 other events

Deaths: 63 deaths

Serious adverse events

Serious adverse events
Measure	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 participants at risk Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=7 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=12 participants at risk Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=81 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine n=78 participants at risk Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Acute myocardial infarction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 arrest	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 congestive	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Cardio-respiratory arrest	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Amaurosis fugax	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Ascites	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Colitis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Duodenal obstruction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Duodenal stenosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Duodenal ulcer	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Gastrointestinal haemorrhage	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Gastrointestinal necrosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Haematemesis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 obstruction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 perforation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Melaena	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Obstruction gastric	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Pancreatic cyst	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Proctitis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Biliary obstruction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Cholangitis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Cholestasis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Portal vein thrombosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Biliary tract infection	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Colonic abscess	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Covid-19	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 bacteraemia	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Enterocolitis infectious	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Escherichia urinary tract infection	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Gastroenteritis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Kidney infection	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Liver abscess	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Peritonitis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Pneumocystis jirovecii pneumonia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 8/78 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 klebsiella	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Postoperative wound infection	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Wound infection	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Anastomotic ulcer	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Drain site complication	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Lumbar vertebral fracture	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Hypoglycaemia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Vitamin b12 deficiency	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Flank pain	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Cerebrovascular accident	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Embolic stroke	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Ischaemic cerebral infarction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Leukoencephalopathy	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Presyncope	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Subarachnoid haemorrhage	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Transient ischaemic attack	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Mental status changes	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Chronic obstructive pulmonary disease	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 thrombosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Abdominal cavity drainage	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine n=3 participants at risk Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=7 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine n=12 participants at risk Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine n=81 participants at risk Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.	Phase 2: Placebo + Nab-paclitaxel + Gemcitabine n=78 participants at risk Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Number of events 8 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	41.7% 5/12 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	56.8% 46/81 • Number of events 186 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	57.7% 45/78 • Number of events 165 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Iron deficiency anaemia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 13 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 53 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.5% 16/78 • Number of events 70 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	41.7% 5/12 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 19 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 12/78 • Number of events 93 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 bradycardia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Eye haemorrhage	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Eye swelling	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Ocular hyperaemia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 discomfort	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 6/12 • Number of events 12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 21 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.5% 16/78 • Number of events 22 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Ascites	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	57.1% 4/7 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 4/12 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.2% 22/81 • Number of events 26 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.5% 30/78 • Number of events 31 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	58.3% 7/12 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	49.4% 40/81 • Number of events 72 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.5% 30/78 • Number of events 58 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Dysphagia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Lip swelling	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 6/12 • Number of events 15 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	40.7% 33/81 • Number of events 46 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 39/78 • Number of events 62 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Paraesthesia oral	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 9/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 26 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 19/78 • Number of events 23 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 10/78 • Number of events 18 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 12/78 • Number of events 17 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.9% 3/7 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	75.0% 9/12 • Number of events 19 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	65.4% 53/81 • Number of events 74 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	56.4% 44/78 • Number of events 84 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 General physical health deterioration	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 14 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 3/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	41.7% 5/12 • Number of events 8 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 43 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	35.9% 28/78 • Number of events 44 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 30 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.9% 21/78 • Number of events 28 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Bile duct stenosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Allergy to arthropod bite	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Seasonal allergy	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 3/78 • Number of events 8 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Infection	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Nasopharyngitis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Postoperative wound infection	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 3/78 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 8/78 • Number of events 16 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Ankle fracture	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 6/78 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Incisional hernia	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Skin abrasion	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Skin laceration	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Activated partial thromboplastin time prolonged	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 28 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 14/78 • Number of events 26 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 38 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 13/78 • Number of events 20 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 23 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 9/78 • Number of events 20 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 9/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 potassium decreased	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 13 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Liver function test increased	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 88 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.0% 7/78 • Number of events 34 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	66.7% 2/3 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.9% 3/7 • Number of events 15 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 4/12 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	38.3% 31/81 • Number of events 184 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	32.1% 25/78 • Number of events 128 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 134 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	39.7% 31/78 • Number of events 106 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 36 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 9/78 • Number of events 14 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 127 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.5% 16/78 • Number of events 92 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	27.2% 22/81 • Number of events 26 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.8% 24/78 • Number of events 37 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.3% 14/81 • Number of events 20 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 15/78 • Number of events 30 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Hyperlipidaemia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Hypoalbuminaemia	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 60 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 3/78 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 40 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.8% 17/78 • Number of events 31 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 12/78 • Number of events 20 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	42.9% 3/7 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 41 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 6/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Vitamin d deficiency	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.0% 7/78 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.1% 11/78 • Number of events 13 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Joint effusion	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 14 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 8/78 • Number of events 12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 6/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Spinal pain	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Balance disorder	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Cognitive disorder	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 26 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	26.9% 21/78 • Number of events 30 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 13/78 • Number of events 15 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Formication	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 10/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 9 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 18/81 • Number of events 36 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	15.4% 12/78 • Number of events 23 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Neurotoxicity	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	3.8% 3/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	21.8% 17/78 • Number of events 30 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Presyncope	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Restless legs syndrome	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Agitation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 8/78 • Number of events 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Delirium	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 11 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	14.1% 11/78 • Number of events 13 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Restlessness	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Chronic kidney disease	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Dysuria	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Pollakiuria	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 tract obstruction	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vulvovaginal pruritus	50.0% 1/2 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/29 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/35 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 14 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 10/78 • Number of events 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	28.6% 2/7 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.3% 14/81 • Number of events 17 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 13/78 • Number of events 25 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.3% 8/78 • Number of events 10 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Rhinorrhoea	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 6/12 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	34.6% 28/81 • Number of events 34 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.5% 16/78 • Number of events 21 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 allergic	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 multiforme	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Hyperhidrosis	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 disorder	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.4% 5/78 • Number of events 5 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 3/12 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 13/78 • Number of events 22 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.0% 7/78 • Number of events 8 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 burning sensation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 lesion	33.3% 1/3 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Urticaria	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Central venous catheterisation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Dental implantation	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Pancreatic pseudocyst drainage	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/78 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 4 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.6% 2/78 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/12 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 14 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 4/78 • Number of events 6 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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	33.3% 1/3 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 29 Months) All participants in phase 1b/2 who received at least one 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% 2/12 • Number of events 2 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.3% 14/81 • Number of events 18 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.7% 6/78 • Number of events 7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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 Lymphoedema	0.00% 0/3 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/7 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one dose of study 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 29 Months) All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.3% 1/78 • Number of events 1 • Baseline to Follow-up (Up To 29 Months) All participants in phase 1b/2 who received at least one 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