Trial Outcomes & Findings for A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body (NCT NCT02014116)

NCT ID: NCT02014116

Last Updated: 2019-12-27

Results Overview

Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

51 participants

Primary outcome timeframe

Cycle 1 (28 Days)

Results posted on

2019-12-27

Participant Flow

The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.

Participant milestones

Participant milestones
Measure	Cohort 1 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 2 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 3 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 4 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 5 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 6 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort A 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort B 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort C 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose confirmation Phase
Overall Study STARTED	3	4	3	7	2	16	1	5	10
Overall Study Received at Least One Dose of Study Drug	3	4	3	7	2	16	1	5	10
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	4	3	7	2	16	1	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 2 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 3 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 4 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 5 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 6 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort A 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort B 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort C 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose confirmation Phase
Overall Study Progressive Disease	3	4	2	6	1	13	1	3	7
Overall Study Adverse Event	0	0	0	0	1	0	0	1	0
Overall Study Lost to Follow-up	0	0	0	0	0	1	0	0	1
Overall Study Death	0	0	0	0	0	0	0	1	1
Overall Study Withdrawal by Subject	0	0	1	1	0	1	0	0	0
Overall Study Withdrawal Caregiver Decision	0	0	0	0	0	1	0	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=3 Participants 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 2 n=4 Participants 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 3 n=3 Participants 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 4 n=7 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 5 n=2 Participants 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort 6 n=16 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Escalation Phase	Cohort A n=1 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort B n=5 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Cohort C n=10 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle. Dose Confirmation Phase	Total n=51 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	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	13 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	36 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	15 Participants n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	9 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	5 Participants n=42 Participants	28 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	23 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	2 Participants n=21 Participants	14 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants	10 Participants n=42 Participants	49 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	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	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants	2 participants n=21 Participants	11 participants n=8 Participants	1 participants n=8 Participants	3 participants n=24 Participants	2 participants n=42 Participants	36 participants n=42 Participants
Region of Enrollment France	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	3 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	8 participants n=42 Participants	11 participants n=42 Participants
Region of Enrollment Australia	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	2 participants n=24 Participants	0 participants n=42 Participants	2 participants n=42 Participants
Region of Enrollment Spain	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	2 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	2 participants n=42 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 Days)

Population: All participants in Part A who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=35 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Maximum Tolerated Dose (MTD) of LY3009120	300 milligrams (mg)	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline through progressive disease (Up to 7.36 months)

Population: All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.

Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=1 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=5 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=10 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Number of Participants With Tumor Response Complete Repsonse	0 participants	0 participants	0 participants	—	—	—
Number of Participants With Tumor Response Partial Response	0 participants	0 participants	0 participants	—	—	—
Number of Participants With Tumor Response Stable Disease	0 participants	0 participants	5 participants	—	—	—
Number of Participants With Tumor Response Progressive Disease	1 participants	4 participants	1 participants	—	—	—
Number of Participants With Tumor Response Not Assessed	0 participants	1 participants	4 participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose

Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.

PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=4 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=15 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=7 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 n=2 Participants 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1	105.29 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 228.24	436 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 96	675 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 81	976 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 72	688 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 46	1717.76 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 1464.86

SECONDARY outcome

Timeframe: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Population: All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=2 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=11 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=4 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15	420.3 ng/mL Geometric Coefficient of Variation 241.2	515 ng/mL Geometric Coefficient of Variation 75	704.74 ng/mL Geometric Coefficient of Variation 1267.39	1430 ng/mL Geometric Coefficient of Variation 66	775 ng/mL Geometric Coefficient of Variation 19	—

SECONDARY outcome

Timeframe: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.

PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=7 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=3 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28	587.75 ng/mL Geometric Coefficient of Variation 206.15	550 ng/mL Geometric Coefficient of Variation 113	594 ng/mL Geometric Coefficient of Variation 32	1150 ng/mL Geometric Coefficient of Variation 69	670 ng/mL Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.

PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=4 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=14 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=6 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 n=2 Participants 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1	960 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 1540	2360 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 56	4640 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 28	7560 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 47	5910 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 23	16,400 nanogram times hour/milliliter(ng*hr/mL) Geometric Coefficient of Variation 14,700

SECONDARY outcome

Timeframe: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 15, per protocol.

PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\].

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=2 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=11 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=4 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15	2240 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 1310	3520 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 7920	5140 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 6260	8460 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 60	5440 nanogramhour/milliliter (nghr/mL) Geometric Coefficient of Variation 17	—

SECONDARY outcome

Timeframe: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.

PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].

Outcome measures

Outcome measures
Measure	Part A LY3009120 n=2 Participants Cohort 1: 50 mg LY3009210 every 12 hours (hr) in a 28-day cycle. Cohort 2 100 mg LY3009210 every 12 hr in a 28-day cycle. Cohort 3: 200 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 4: 400 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 5: 500 mg LY3009120 every 12 hr in a 28-day cycle. Cohort 6: 300 mg LY3009120 every 12 hr in a 28-day cycle.	Cohort B n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=3 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	300 mg LY3009120 n=7 Participants 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	400 mg LY3009120 n=3 Participants 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	500 mg LY3009120 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28	3120 ng*hr/mL Geometric Coefficient of Variation 1300	3100 ng*hr/mL Geometric Coefficient of Variation 102	5200 ng*hr/mL Geometric Coefficient of Variation 7	6580 ng*hr/mL Geometric Coefficient of Variation 47	4640 ng*hr/mL Geometric Coefficient of Variation 18	—

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort 3

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort 4

Serious events: 5 serious events

Other events: 7 other events

Deaths: 5 deaths

Cohort 5

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 6

Serious events: 12 serious events

Other events: 16 other events

Deaths: 4 deaths

Cohort A

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort B

Serious events: 5 serious events

Other events: 5 other events

Deaths: 4 deaths

Cohort C

Serious events: 6 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=3 participants at risk 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 2 n=4 participants at risk 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 3 n=3 participants at risk 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 4 n=7 participants at risk 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 5 n=2 participants at risk 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 6 n=16 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort A n=1 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort B n=5 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=10 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Cardiac disorders Angina pectoris	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders General physical health deterioration	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Hyperthermia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Cognitive disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Hemiparesis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	18.8% 3/16 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Cohort 1 n=3 participants at risk 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 2 n=4 participants at risk 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 3 n=3 participants at risk 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 4 n=7 participants at risk 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 5 n=2 participants at risk 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort 6 n=16 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort A n=1 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort B n=5 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.	Cohort C n=10 participants at risk 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
General disorders Chills	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Facial pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Fatigue	33.3% 1/3 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	75.0% 3/4 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	85.7% 6/7 • Number of events 8 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	43.8% 7/16 • Number of events 11 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Gait disturbance	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Ill-defined disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Localised oedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 4/16 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Ear and labyrinth disorders Deafness	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Eye discharge	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Eye haemorrhage	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Eye irritation	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Macular oedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Periorbital oedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Retinal vascular disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Retinopathy	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Vision blurred	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Eye disorders Visual impairment	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	42.9% 3/7 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	42.9% 3/7 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 2/2 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	43.8% 7/16 • Number of events 10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	18.8% 3/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	57.1% 4/7 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	37.5% 6/16 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Retching	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	57.1% 4/7 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	18.8% 3/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Asthenia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Mucosal dryness	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Mucosal inflammation	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Oedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 4/16 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Performance status decreased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Peripheral swelling	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
General disorders Xerosis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Candida infection	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Cystitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Paronychia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Rash pustular	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Infections and infestations Viral parotitis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Face injury	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	42.9% 3/7 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	42.9% 3/7 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	18.8% 3/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Breath sounds abnormal	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Cardiac murmur	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Troponin increased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	42.9% 3/7 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	37.5% 6/16 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 8 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 2/2 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	57.1% 4/7 • Number of events 5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	66.7% 2/3 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Akathisia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Cognitive disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Memory impairment	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Migraine with aura	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Partial seizures	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Radicular pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Somnolence	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Nervous system disorders Speech disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Agitation	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Hallucination	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Psychiatric disorders Restlessness	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Choluria	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Costovertebral angle tenderness	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Renal and urinary disorders Urge incontinence	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/9 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	— 0/0 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 2/4 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 4/16 • Number of events 7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	60.0% 3/5 • Number of events 4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 5/10 • Number of events 9 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	28.6% 2/7 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	18.8% 3/16 • Number of events 6 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	100.0% 1/1 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Nail dystrophy	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	40.0% 2/5 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	12.5% 2/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin plaque	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Flushing	33.3% 1/3 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	14.3% 1/7 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	50.0% 1/2 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Lymphoedema	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	6.2% 1/16 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/5 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.
Vascular disorders Pallor	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/4 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/3 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/7 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/2 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/16 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	20.0% 1/5 • Number of events 1 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.	0.00% 0/10 • Baseline to Study Completion (Up to 33 months) All participants who received at least one dose of study drug.

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