Trial Outcomes & Findings for A Study of LY2157299 in Participants With Hepatocellular Carcinoma (NCT NCT01246986)

NCT ID: NCT01246986

Last Updated: 2021-01-12

Results Overview

Biomarker response was defined as a \> 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment. Data presented is median overall survival of those participants who achieved the defined biomarker response. Participants enrolled in Part A had a baseline AFP level of \>1.5 upper limit normal (ULN). Participants enrolled in Part B had baseline AFP level \<1.5 ULN.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 204 participants
• Primary outcome timeframe: Baseline, discontinuation from any cause (Up to 83 months)
• Results posted on: 2021-01-12

Participant Flow

Participants who had progressive disease or death are defined as completed. Per the protocol, following an interim analysis, the decision was taken to no longer randomize participants to the 160 mg LY2157299 arm.

Participant milestones

Measure	Part A Cohort 1 - 160 mg LY2157299 80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle).	Part A Cohort 2 - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 1 - 160 mg LY2157299 + Sorafenib 80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab 80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).	Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab 150 mg LY2157299 given twice orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
Overall Study STARTED	37	72	40	3	44	3	5
Overall Study Received at Least 1 Dose of Study Drug	37	72	40	3	44	3	5
Overall Study COMPLETED	34	67	34	3	40	2	5
Overall Study NOT COMPLETED	3	5	6	0	4	1	0

Reasons for withdrawal

Measure	Part A Cohort 1 - 160 mg LY2157299 80 mg LY2157299 given orally twice daily (BID) for 14 days followed by 14 days off (28-day cycle).	Part A Cohort 2 - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 1 - 160 mg LY2157299 + Sorafenib 80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab 80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).	Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab 150 mg LY2157299 given twice orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
Overall Study Lost to Follow-up	0	1	3	0	0	1	0
Overall Study Withdrawal by Subject	3	4	3	0	4	0	0

Baseline Characteristics

A Study of LY2157299 in Participants With Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle)..	Part A Cohort 2 - 300 mg LY2157299 n=72 Participants 150mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B - 300 mg LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 1 - 160 mg LY2157299 + Sorafenib n=3 Participants 80 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab n=3 Participants 80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kilogram (kg) intravenous (IV) on days 1 and 15 (28-day cycle).	Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab n=5 Participants 150 mg LY2157299 given twice BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).	Total n=204 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	63.3 years STANDARD_DEVIATION 10.8 • n=7 Participants	68.1 years STANDARD_DEVIATION 9.6 • n=5 Participants	70.3 years STANDARD_DEVIATION 4.7 • n=4 Participants	63.7 years STANDARD_DEVIATION 9.8 • n=21 Participants	54.0 years STANDARD_DEVIATION 11.3 • n=10 Participants	63.2 years STANDARD_DEVIATION 11.2 • n=115 Participants	64.3 years STANDARD_DEVIATION 10.5 • n=6 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	27 Participants n=6 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	59 Participants n=7 Participants	36 Participants n=5 Participants	3 Participants n=4 Participants	39 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	177 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants	21 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	9 Participants n=6 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	9 Participants n=6 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	58 Participants n=7 Participants	35 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	149 Participants n=6 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	15 Participants n=6 Participants
Region of Enrollment New Zealand	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	12 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	23 Participants n=6 Participants
Region of Enrollment United States	6 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	3 Participants n=10 Participants	5 Participants n=115 Participants	41 Participants n=6 Participants
Region of Enrollment Italy	12 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	40 Participants n=6 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	5 Participants n=6 Participants
Region of Enrollment France	12 Participants n=5 Participants	27 Participants n=7 Participants	16 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	69 Participants n=6 Participants
Region of Enrollment Germany	4 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	21 Participants n=6 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	5 Participants n=6 Participants
Alpha-Fetoprotein < 200 nanograms per Liter (µg/L)	9 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	85 Participants n=6 Participants
Alpha-Fetoprotein 200 - 400 (µg/L)	3 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	12 Participants n=6 Participants
Alpha-Fetoprotein > 400 (µg/L)	23 Participants n=5 Participants	43 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	16 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	87 Participants n=6 Participants
Alpha-Fetoprotein Unknown/Not reported	2 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	20 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline, discontinuation from any cause (Up to 83 months)

Population: All participants who received at least one dose of study drug, achieved a \>20% reduction in biomarker AFP, and had evaluable post-baseline biomarker data. Due to low enrollment into Part C Cohort - 160 mg reporting group, Kaplan Meier analysis for OS was not conducted in this subgroup. Per protocol, Part D collected safety data only.

Biomarker response was defined as a > 20% decrease in the biomarker AFP from baseline during 8 weeks of treatment. Data presented is median overall survival of those participants who achieved the defined biomarker response. Participants enrolled in Part A had a baseline AFP level of >1.5 upper limit normal (ULN). Participants enrolled in Part B had baseline AFP level <1.5 ULN.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=8 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=14 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=10 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=27 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Change From Baseline in Relationship of Biomarker Alpha-fetoprotein (AFP) to Overall Survival (OS)	19.0 Months Interval 1.5 to 25.1	21.5 Months Interval 2.9 to 34.2	24.2 Months Interval 3.0 to Part B 95% Confidence Interval (CI) upper limit non-estimable	17.9 Months Interval 12.6 to 32.8	—

PRIMARY outcome

Timeframe: Baseline,discontinuation from any cause (Up to 83 months)

Population: All participants who received at least one dose of study drug, achieved a \>20% reduction in biomarker TGF-β and had evaluable post-baseline biomarker data. Due to low enrollment in Part C Cohort 1 - 160 mg reporting group, Kaplan Meier analysis for OS was not conducted in this subgroup. Per protocol, Part D collected safety data only.

Biomarker response was defined as a > 20% decrease in the biomarker TGF-B from baseline. Data presented is median overall survival of those participants who achieved biomarker response.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=16 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=34 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=28 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=31 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Change From Baseline in Relationship of Biomarker Transforming Growth Factor - Beta (TGF-β) to Overall Survival (OS)	11.9 Months Interval 5.4 to 15.6	10.1 Months Interval 4.9 to 15.5	21.9 Months Interval 12.4 to Part B 95% CI upper limit was non-estimable.	22.88 Months Interval 16.2 to 31.8	—

PRIMARY outcome

Timeframe: Randomization to date of first measured progressive disease (Up to 36 Weeks)

Population: All participants who receive at least one dose of study drug. Per protocol, Part D collected safety data only.

TTP is measured from the date of first dose to the first date of progression of disease based on the investigator review of tumor response using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=72 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Time to Progression (TTP)	12.1 Weeks Interval 6.3 to 17.6	7.1 Weeks Interval 6.3 to 12.7	18.0 Weeks Interval 10.0 to 24.0	36.0 Weeks Interval 18.0 to 36.0	17.9 Weeks Interval 12.1 to 24.0

SECONDARY outcome

Timeframe: Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1

Population: All participants who received at least one dose of study drug, regardless of dose, with evaluable PK data. Per protocol, Part D collected safety data only.

Population mean (between-subject coefficient variance [CV %]) apparent clearance.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=143 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Population Pharmacokinetics (PK) Mean Population Clearance of Galunisertib	33.6 Liter per hour (L/hr) Geometric Coefficient of Variation 48	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 (28 Days)

Population: All participants in Part A and Part B.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=74 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Recommended Dose for Phase 3 Hepatocellular Carcinoma (HCC) Trials	300 milligrams (mg)	—	—	—	—

SECONDARY outcome

Timeframe: Randomization to date of death from any cause (Up to 83 months)

Population: All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.

OS duration is measured from the date of first dose to the date of death from any cause.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=72 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Overall Survival (OS)	39.1 Weeks Interval 24.1 to 52.6	29.6 Weeks Interval 19.6 to 38.6	73.0 Weeks Interval 45.4 to 104.7	30.3 Weeks Interval 28.4 to 70.3	89.6 Weeks Interval 70.3 to 104.9

SECONDARY outcome

Timeframe: Randomization to measured progressive disease or death from any cause (Up to 45 Weeks)

Population: All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.

PFS duration is measure from the date of first dose to the first date of objective progression of disease or death from any cause. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=72 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Progression Free Survival (PFS)	12 Weeks Interval 6.3 to 12.6	6.6 Weeks Interval 6.1 to 10.9	13.4 Weeks Interval 7.4 to 23.3	28.4 Weeks Interval 6.0 to 36.0	28.4 Weeks Interval 17.4 to 45.3

SECONDARY outcome

Timeframe: Randomization to measured progressive disease (Up to 36 Weeks)

Population: All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.

The percentage of participants who achieved best overall response of either Complete Response (CR) or Partial Response (PR). The overall response rate for each dose with be estimated by dividing the number of confirmed responders by the number of participants who received at least one dose of study drug. Per RECIST v.1.0 criteria CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=30 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=46 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=27 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Percentage of Participants Achieving an Objective Response (Response Rate) Complete Response	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Achieving an Objective Response (Response Rate) Partial Response	0 percentage of participants	0 percentage of participants	3.7 percentage of participants	0 percentage of participants	2.3 percentage of participants

SECONDARY outcome

Timeframe: Time of response to measured progressive disease or death from any cause (Up to 84 Weeks)

Population: All participants who received at least one dose of study drug with assessment of CR or PR. Per protocol, Part D collected safety data only.

DoR is measured from the date of the first objective status assessment of a Complete Response (CR) or Partial Response (PR), as determined by RECIST v1.1, to the first date of objective progression of disease or death from any cause. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is defined as at least 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=2 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=4 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Duration of Tumor Response (DoR)	—	—	37.6 Weeks Interval 25.1 to 50.1	—	40.2 Weeks Interval 12.1 to 84.1

SECONDARY outcome

Timeframe: Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause (Up to 75 Weeks)

Population: All participants who received at least one dose of study drug. Per protocol, Part D collected safety data only.

TTF is measured from the date of first dose until the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=72 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Time to Treatment Failure (TTF)	13.4 Weeks Interval 8.6 to 18.0	9.9 Weeks Interval 8.1 to 12.1	19.3 Weeks Interval 12.1 to 26.3	26.3 Weeks Interval 19.3 to 54.0	49.3 Weeks Interval 18.3 to 75.3

SECONDARY outcome

Timeframe: Baseline, Day 1 Cycle 4

Population: All participants with baseline and one post-baseline FACT-Hep Questionnaire in Cycles 2, 3, or 4. Per protocol, Part D collected safety data only.

FACT-Hep consists of 45 items in five subscales (1) physical well-being (PWB) score rage 0 -28; (2) social well-being (SWB) score range 0-28; (3) emotional well-being (EWB) score range 0-24; (4) functional well-being (FWB) score range 0-28; and (5) the hepatobiliary cancer subscale (HCS) Score range 0-72; FACT-Hep score range 1-180, and Trial-Outcome Index (TOI) score range 1-128, to assess health related quality of life in participants with cancer. Higher scores reflect a better health state.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=30 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=51 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=38 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=3 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=39 Participants 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score SWB	0.96 units on a scale Standard Deviation 2.9	0.24 units on a scale Standard Deviation 3.4	0.37 units on a scale Standard Deviation 4.5	-1.11 units on a scale Standard Deviation 2.8	0.41 units on a scale Standard Deviation 3.6
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score FACT-Hep	2.04 units on a scale Standard Deviation 1.53	1.50 units on a scale Standard Deviation 17.5	0.58 units on a scale Standard Deviation 18.2	-0.50 units on a scale Standard Deviation 6.5	-8.54 units on a scale Standard Deviation 17.0
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score TOI	1.34 units on a scale Standard Deviation 13.3	1.14 units on a scale Standard Deviation 14.6	1.17 units on a scale Standard Deviation 12.2	-1.92 units on a scale Standard Deviation 7.7	-8.28 units on a scale Standard Deviation 13.7
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score PWB	0.06 units on a scale Standard Deviation 3.6	-0.16 units on a scale Standard Deviation 5.0	0.04 units on a scale Standard Deviation 3.4	-1.67 units on a scale Standard Deviation 1.5	-1.75 units on a scale Standard Deviation 4.4
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score EWB	0.55 units on a scale Standard Deviation 2.7	1.17 units on a scale Standard Deviation 3.9	1.13 units on a scale Standard Deviation 4.1	2.87 units on a scale Standard Deviation 2.8	0.85 units on a scale Standard Deviation 2.5
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score FWB	-0.02 units on a scale Standard Deviation 5.3	0.84 units on a scale Standard Deviation 3.6	1.20 units on a scale Standard Deviation 4.7	-1.00 units on a scale Standard Deviation 1.0	-1.19 units on a scale Standard Deviation 4.6
Change From Baseline in Functional Assessment of Cancer Therapy, Hepatobiliary (FACT-Hep) Sub-scores and Total Score HCS	1.93 units on a scale Standard Deviation 7.6	1.40 units on a scale Standard Deviation 7.8	0.89 units on a scale Standard Deviation 6.8	1.08 units on a scale Standard Deviation 6.0	-3.79 units on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline to the worsening of symptoms (up to 567 days)

Population: All participants who completed a baseline and one post-baseline FACT-Hep TTW questionnaire. Due to low enrollment in Part C Cohort 1 - 160 mg reporting group, time-to-event analysis for TTW was not conducted for this subgroup. Per protocol, Part D collected safety data only.

Time to worsening of symptoms used minimally important differences to evaluate Physical Well Being (PWB), Functional Well Being (FWB), Hepatocellular Cancer Symptoms (HCS), National Comprehensive Cancer Network (NCCN)/FACT Hepatocellular Symptoms (FHS), Trial-Outcome Index (TOI). PWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; FWB time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; HCS time to worsening was defined as participants who had change in a subscale of ≥ 5 point decrease from baseline; FHS time to worsening was defined as participants who had change in a subscale of ≥ 2 point decrease from baseline; TOI time to Worsening was defined as participants who had change in the subscale of ≥ 7 point decrease from baseline.

Outcome measures

Measure	Part A Cohort 1 - 160 mg LY2157299 n=30 Participants 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle) for Cohort 1.	Part A Cohort 2 - 300 mg LY2157299 n=61 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B LY2157299 n=37 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C LY2157299 n=40 Participants 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib 150 mg LY2157299 given orally BID on Days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day
Time to Worsening (TTW) of Symptoms (FACT-Hep) PWB	114.0 Days Interval 30.0 to Upper value of CI was non estimable	113.0 Days Interval 57.0 to Upper value of CI was non estimable	113.0 Days Interval 58.0 to 170.0	30.0 Days Interval 29.0 to 57.0	—
Time to Worsening (TTW) of Symptoms (FACT-Hep) TOI	114.0 Days Interval 57.0 to Upper value of CI was non estimable	113.0 Days Interval 58.0 to 371.0	179.0 Days Interval 57.0 to 567.0	30.0 Days Interval 29.0 to 31.0	—
Time to Worsening (TTW) of Symptoms (FACT-Hep) FWB	57.0 Days Interval 30.0 to 86.0	88.0 Days Interval 57.0 to 371.0	64.0 Days Interval 30.0 to 172.0	30.0 Days Interval 29.0 to 58.0	—
Time to Worsening (TTW) of Symptoms (FACT-Hep) HCS	114.0 Days Interval 57.0 to Upper value of CI was non estimable	113.0 Days Interval 85.0 to Upper value of CI was non estimable	170.0 Days Interval 57.0 to 567.0	31.0 Days Interval 29.0 to 57.0	—
Time to Worsening (TTW) of Symptoms (FACT-Hep) FHS	55.0 Days Interval 29.0 to 86.0	57.0 Days Interval 30.0 to 113.0	57.0 Days Interval 30.0 to 113.0	30.0 Days Interval 29.0 to 30.0	—

Adverse Events

Part A Cohort 1 - 160 mg LY2157299

Serious events: 15 serious events

Other events: 32 other events

Deaths: 33 deaths

Part A Cohort 2 - 300 mg LY2157299

Serious events: 36 serious events

Other events: 64 other events

Deaths: 63 deaths

Part B - 300 mg LY2157299

Serious events: 16 serious events

Other events: 38 other events

Deaths: 26 deaths

Part C Cohort 1 - 160 mg LY2157299 + Sorafenib

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Part C Cohort 2 - 300 mg LY2157299 + Sorafenib

Serious events: 28 serious events

Other events: 44 other events

Deaths: 36 deaths

Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 participants at risk 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part A Cohort 2 - 300 mg LY2157299 n=72 participants at risk 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B - 300 mg LY2157299 n=40 participants at risk 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 1 - 160 mg LY2157299 + Sorafenib n=3 participants at risk 80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 participants at risk 150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab n=3 participants at risk 80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).	Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab n=5 participants at risk 150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
Metabolism and nutrition disorders Hyperammonaemia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.7% 7/72 • Number of events 16 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 3/40 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina unstable	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Atrial thrombosis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Cardiac failure	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Left ventricular dysfunction	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Left ventricular failure	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 4/72 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastric varices haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haematemesis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Intra-abdominal haemorrhage	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Large intestinal haemorrhage	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Melaena	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oesophageal varices haemorrhage	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Peritoneal haematoma	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Subileus	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Varices oesophageal	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest discomfort	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders General physical health deterioration	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic failure	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic haematoma	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic haemorrhage	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatic pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Jaundice cholestatic	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Anal abscess	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Arthritis bacterial	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Diverticulitis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Endocarditis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Liver abscess	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Osteomyelitis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Peritonitis bacterial	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pneumonia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 4/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Sepsis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Wound infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Concussion	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Shunt stenosis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Liver function test abnormal	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Fluid retention	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Embolic stroke	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Encephalopathy	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Haemorrhage intracranial	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hepatic encephalopathy	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Loss of consciousness	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Presyncope	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	2.7% 1/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Disorientation	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Prerenal failure	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal disorder	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal impairment	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Renal injury	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Dry gangrene	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Shock haemorrhagic	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Thrombosis	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Measure	Part A Cohort 1 - 160 mg LY2157299 n=37 participants at risk 80 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part A Cohort 2 - 300 mg LY2157299 n=72 participants at risk 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part B - 300 mg LY2157299 n=40 participants at risk 150 mg LY2157299 given orally BID for 14 days followed by 14 days off (28-day cycle).	Part C Cohort 1 - 160 mg LY2157299 + Sorafenib n=3 participants at risk 80 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part C Cohort 2 - 300 mg LY2157299 + Sorafenib n=44 participants at risk 150 mg LY2157299 given orally BID on days 1 to 14 in combination with 400 mg Sorafenib BID on days 1 to 28 (28-day cycle).	Part D Cohort 1 - 160 mg LY2157299 + Ramucirumab n=3 participants at risk 80 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).	Part D Cohort 2 - 300 mg LY2157299 + Ramucirumab n=5 participants at risk 150 mg LY2157299 given orally BID on days 1 to 14 in combination with ramucirumab 8 mg/kg IV on days 1 and 15 (28-day cycle).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	24.3% 9/37 • Number of events 22 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.1% 13/72 • Number of events 23 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 10/40 • Number of events 20 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	27.3% 12/44 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	8.1% 3/37 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 3/40 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.9% 7/44 • Number of events 22 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 3/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 5/40 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	18.9% 7/37 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.3% 11/72 • Number of events 12 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 8/40 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.9% 7/44 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 2/5 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.7% 7/72 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 4/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	13.5% 5/37 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 8/72 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	13.5% 5/37 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.3% 11/72 • Number of events 14 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	17.5% 7/40 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	13.5% 5/37 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.9% 10/72 • Number of events 13 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	27.5% 11/40 • Number of events 15 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	47.7% 21/44 • Number of events 43 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 4/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Flatulence	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival bleeding	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	16.2% 6/37 • Number of events 11 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.8% 15/72 • Number of events 21 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.5% 9/40 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	27.3% 12/44 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Varices oesophageal	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	16.2% 6/37 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	16.7% 12/72 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.0% 6/40 • Number of events 11 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 11 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	13.5% 5/37 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 6/72 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 4/40 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 14 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	8.1% 3/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	24.3% 9/37 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	19.4% 14/72 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	35.0% 14/40 • Number of events 15 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 11/44 • Number of events 16 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 2/5 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 4/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Localised oedema	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	13.5% 5/37 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	19.4% 14/72 • Number of events 16 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 12/40 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.7% 10/44 • Number of events 12 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	5.4% 2/37 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 6/72 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 13 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	8.1% 3/37 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bronchitis	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 4/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Furuncle	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Post abortion infection	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vaginal infection	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral infection	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/13 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 2/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Haemoglobin decreased	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	10.8% 4/37 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.1% 8/72 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	25.0% 10/40 • Number of events 17 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	100.0% 3/3 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	54.5% 24/44 • Number of events 58 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight increased	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.7% 7/72 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	16.2% 6/37 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.7% 7/72 • Number of events 8 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	17.5% 7/40 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.7% 10/44 • Number of events 15 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	8.1% 3/37 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 3/37 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 5/40 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	5.4% 2/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 5/72 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 5/40 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	13.6% 6/44 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	66.7% 2/3 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.7% 10/44 • Number of events 11 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 5/72 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	10.8% 4/37 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Embolic stroke	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 4/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 5/40 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Hepatic encephalopathy	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	8.1% 3/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Somnolence	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Taste disorder	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Anxiety	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.6% 4/72 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 5/72 • Number of events 6 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 4/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Nocturia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Erectile dysfunction	3.1% 1/32 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/59 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/36 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 2/39 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	8.1% 3/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.9% 5/72 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 3/40 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.1% 3/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 9/72 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.0% 6/40 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	11.4% 5/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 1/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	7.5% 3/40 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	100.0% 3/3 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 1/5 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.5% 9/44 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	4.2% 3/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	15.9% 7/44 • Number of events 7 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Night sweats	5.4% 2/37 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/44 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	63.6% 28/44 • Number of events 61 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	18.9% 7/37 • Number of events 9 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	12.5% 9/72 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 8/40 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	27.3% 12/44 • Number of events 16 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	22.7% 10/44 • Number of events 11 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.1% 3/37 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	33.3% 1/3 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.3% 1/44 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin lesion	2.7% 1/37 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/72 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Flushing	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.8% 2/72 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/40 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	6.8% 3/44 • Number of events 3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Haematoma	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 1/40 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 4/44 • Number of events 4 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/37 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	1.4% 1/72 • Number of events 1 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	5.0% 2/40 • Number of events 2 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	18.2% 8/44 • Number of events 10 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/3 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/5 • Baseline up to 41.5 months All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60